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lcds-datatable--ckeditor"> <table class="table table-striped table-border" data-column-defs="[{ "targets": 0, "type": "date" }]" data-excel-button="true" data-order="[ 0, "desc" ]" data-paging="true" data-searching="true" summary="Drug Alerts and Statements"> <thead> <tr> <th scope="col">Date</th> <th scope="col" style="width: 80%;">Title</th> </tr> </thead> <tbody> <tr> <td>11/1/2024</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="23ad391f-db9d-49d3-8e59-9f0283896f09" href="/drugs/drug-safety-and-availability/fda-warns-patients-and-health-care-professionals-not-use-compounded-drugs-fullerton-wellness" title="FDA warns patients and health care professionals not to use compounded drugs from Fullerton Wellness">FDA warns patients and health care professionals not to use compounded drugs from Fullerton Wellness</a></td> </tr> <tr> <td>10/30/2024</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="1c115d37-abbe-4b51-9492-6728a5312a0a" href="/drugs/drug-safety-and-availability/do-not-purchase-or-use-skin-cap-aerosol-spray-products-because-they-may-be-harmful-your-health" title="Do not purchase or use Skin-Cap Aerosol Spray Products because they may be harmful to your health">Do not purchase or use Skin-Cap Aerosol Spray Products because they may be harmful to your health</a></td> </tr> <tr> <td>10/2/2024</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="c0e084af-268f-4b83-8187-4ea7226ce408" href="/drugs/drug-safety-and-availability/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize" title="FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize">FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize</a></td> </tr> <tr> <td>9/26/2024</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="e538861e-f888-4fca-8b99-6621255071b7" href="/drugs/drug-safety-and-availability/fda-alerting-patients-and-health-care-professionals-about-voluntary-withdrawal-oxbryta-market-due" title="FDA is alerting patients and health care professionals about the voluntary withdrawal of Oxbryta from the market due to safety concerns ">FDA is alerting patients and health care professionals about the voluntary withdrawal of Oxbryta from the market due to safety concerns</a></td> </tr> <tr> <td>9/18/2024</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="2c574db6-0bd9-43c0-930d-90af474c236c" href="/drugs/drug-safety-and-availability/fda-warns-consumers-not-use-snorestop-nasal-spray-green-pharmaceuticals-due-potential-contamination" title="FDA warns consumers not to use SnoreStop Nasal Spray by Green Pharmaceuticals due to potential contamination ">FDA warns consumers not to use SnoreStop Nasal Spray by Green Pharmaceuticals due to potential contamination</a></td> </tr> <tr> <td>9/5/2024</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="a3ba566b-a019-44e5-8618-f8baf2a2b2c3" href="/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-umary-and-amazy-products-they-may-be-harmful-your-health" title="FDA warns consumers not to purchase or use Umary and Amazy products as they may be harmful to your health">FDA warns consumers not to purchase or use Umary and Amazy products as they may be harmful to your health</a></td> </tr> <tr> <td>8/6/2024</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="4d2a6116-2349-4b84-846a-4495c12189e3" href="/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-unapproved-inhalant-products-marketed-alertness-and-energy" title="FDA warns consumers to not purchase or use unapproved inhalant products marketed for alertness and energy boosting">FDA warns consumers to not purchase or use unapproved inhalant products marketed for alertness and energy boosting</a></td> </tr> <tr> <td>7/30/2024</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="934701b2-c0e5-464a-aa62-040bbffb753d" href="/drugs/drug-safety-and-availability/fda-warns-against-purchasing-or-using-chemical-peel-skin-products-without-professional-supervision" title="FDA warns against purchasing or using chemical peel skin products without professional supervision">FDA warns against purchasing or using chemical peel skin products without professional supervision</a></td> </tr> <tr> <td>5/16/2024</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="eee17b87-1ade-4137-993a-5bc0297b466f" href="/drugs/drug-safety-and-availability/fda-alerts-patients-caregivers-and-health-care-providers-cross-compatibility-issues-autoinjector" title="FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection">FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection</a></td> </tr> <tr> <td>4/29/2024</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="7e88fd43-64f4-4156-898d-95de6fa6d563" href="/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-pregnancy-problems-associated-thiopurines" title="FDA alerts health care professionals of pregnancy problems associated with thiopurines">FDA alerts health care professionals of pregnancy problems associated with thiopurines</a></td> </tr> <tr> <td>4/16/2024</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="c53a16fe-a341-4616-acb1-d9d318b313aa" href="/drugs/drug-safety-and-availability/counterfeit-version-botox-found-multiple-states" title="Counterfeit Version of Botox Found in Multiple States">Counterfeit Version of Botox Found in Multiple States</a></td> </tr> <tr> <td>2/23/2024</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="3e524d37-0210-4cfc-ba8a-2674f1968aaf" href="/drugs/drug-safety-and-availability/fda-issues-final-decision-withdraw-approval-pepaxto-melphalan-flufenamide" title="FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)">FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)</a></td> </tr> <tr> <td>1/31/2024</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="e48aba55-482d-42e7-9cd7-210a6e9bd303" href="/drugs/drug-safety-and-availability/fda-warns-consumers-contaminated-copycat-eye-drops" title="FDA warns consumers of contaminated copycat eye drops">FDA warns consumers of contaminated copycat eye drops</a></td> </tr> <tr> <td>1/17/2024</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="17fda2be-81bc-4ddb-90d6-005056bc79f3" href="/drugs/drug-safety-and-availability/fda-announces-shelf-life-extension-naloxone-nasal-spray" title="FDA announces shelf-life extension for naloxone nasal spray">FDA announces shelf-life extension for naloxone nasal spray</a></td> </tr> <tr> <td>12/27/2023</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="84a2bd9f-ede5-457b-b18c-1e30396c75ba" href="/drugs/drug-safety-and-availability/fda-requires-updates-labeling-promethazine-hydrochloride-injection-products" title="FDA requires updates to labeling for promethazine hydrochloride injection products">FDA requires updates to labeling for promethazine hydrochloride injection products</a></td> </tr> <tr> <td>11/21/2023</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="bc4a15e2-bf34-46d8-827c-417a532fad14" href="/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-neptunes-fix-or-any-tianeptine-product-due-serious-risks" title="FDA warns consumers not to purchase or use Neptune’s Fix or any tianeptine product due to serious risks">FDA warns consumers not to purchase or use Neptune’s Fix or any tianeptine product due to serious risks</a></td> </tr> <tr> <td>11/3/2023</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="9a9a8d63-20f9-41bd-bf7b-789eb445f9f4" href="/drugs/drug-safety-and-availability/fda-warns-consumers-hidden-drug-ingredients-dr-ergins-sugarmd-advanced-glucose-support" title="FDA warns consumers of hidden drug ingredients in Dr. Ergin’s SugarMD Advanced Glucose Support">FDA warns consumers of hidden drug ingredients in Dr. Ergin’s SugarMD Advanced Glucose Support</a></td> </tr> <tr> <td>10/27/2023</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="fa510533-f92c-4a9f-a7f1-d334504d9145" href="/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-certain-eye-drops-several-major-brands-due-risk-eye" title="FDA warns consumers not to purchase or use certain eye drops from several major brands due to risk of eye infection">FDA warns consumers not to purchase or use certain eye drops from several major brands due to risk of eye infection</a></td> </tr> <tr> <td>9/18/2023</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="f1d70033-e2b9-4642-9881-a6ff3db6cad9" href="/drugs/drug-safety-and-availability/fda-changing-therapeutic-equivalence-rating-accord-healthcare-incs-generics-prograf-tacrolimus-oral" title="FDA is changing the therapeutic equivalence rating for Accord Healthcare Inc.’s generics of Prograf (tacrolimus) oral capsules  ">FDA is changing the therapeutic equivalence rating for Accord Healthcare Inc.’s generics of Prograf (tacrolimus) oral capsules</a></td> </tr> <tr> <td>8/22/2023</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="44a547a5-6a9e-42d8-909e-0d627fa8fc4a" href="/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-certain-methylsulfonylmethane-msm-eye-drops-due" title="FDA warns consumers not to purchase or use certain methylsulfonylmethane (MSM) eye drops due to contamination">FDA warns consumers not to purchase or use certain methylsulfonylmethane (MSM) eye drops due to contamination</a></td> </tr> <tr> <td>8/1/2023</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="1244e45a-fdb4-4fac-ad1d-4de5917216f1" href="/drugs/drug-safety-and-availability/fda-warns-consumers-tydemy-prescription-oral-contraceptive-may-have-reduced-effectiveness" title="FDA warns consumers that Tydemy, a prescription oral contraceptive, may have reduced effectiveness">FDA warns consumers that Tydemy, a prescription oral contraceptive, may have reduced effectiveness</a></td> </tr> <tr> <td>5/22/2023</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="4c432e1c-d6d0-43c5-9b3f-5baf754bf0fd" href="/drugs/drug-safety-and-availability/g-supress-dx-pediatric-cough-drops-may-have-incorrect-drug-packaging" title="G-Supress DX Pediatric Cough Drops may have incorrect drug in packaging">G-Supress DX Pediatric Cough Drops may have incorrect drug in packaging</a></td> </tr> <tr> <td>5/1/2023</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="99253c07-a949-4181-813c-21f5c1ab52cc" href="/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-nose-slap-and-soul-slap-products-marketed-alertness-and" title="FDA warns consumers to not purchase or use Nose Slap and Soul Slap products marketed for alertness and energy boosting">FDA warns consumers to not purchase or use Nose Slap and Soul Slap products marketed for alertness and energy boosting</a></td> </tr> <tr> <td>2/9/2023</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="deee204a-2508-4ab7-9008-8523f19b0675" href="/drugs/drug-safety-and-availability/infants-risk-aluminum-toxicity-unapproved-potassium-phosphates-drug-product" title="Infants at Risk for Aluminum Toxicity with Unapproved Potassium Phosphates Drug Product">Infants at risk for aluminum toxicity with unapproved potassium phosphates drug product</a></td> </tr> <tr> <td>2/2/2023</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="19344d74-92d8-4b55-a892-1cc670af665c" href="/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-ezricare-artificial-tears-due-potential-contamination" title="FDA warns consumers not to purchase or use EzriCare Artificial Tears due to potential contamination ">FDA warns consumers not to purchase or use EzriCare Artificial Tears due to potential contamination</a> </td> </tr> <tr> <td>11/22/2022</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="c6d34d5a-fb85-4f90-9884-1badb4788801" href="/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-compatibility-issues-prefilled-glass-syringes-and-certain-luer" title="FDA alerts health care professionals of compatibility issues with prefilled glass syringes and certain Luer-activated valve (LAV) connectors ">FDA alerts health care professionals of compatibility issues with prefilled glass syringes and certain Luer-activated valve (LAV) connectors</a> </td> </tr> <tr> <td>11/8/2022</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="0d0a7b9e-2894-40d6-9fac-63c2cd8d3d6d" href="/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-risks-patients-exposed-xylazine-illicit-drugs" title="FDA alerts health care professionals of risks to patients exposed to xylazine in illicit drugs">FDA alerts health care professionals of risks to patients exposed to xylazine in illicit drugs</a></td> </tr> <tr> <td>8/18/2022</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="eee17b87-1ade-4137-993a-5bc0297b466f" href="/drugs/drug-safety-and-availability/fda-alerts-patients-caregivers-and-health-care-providers-cross-compatibility-issues-autoinjector" title="FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection">FDA alerts patients, caregivers, and health care providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection</a></td> </tr> <tr> <td>4/29/2022</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="6b2bbab1-7b6e-4ab3-985f-67996f9d5070" href="/drugs/drug-safety-and-availability/bosentan-rems-requirements-will-change-june-27-2022" title="Bosentan REMS requirements will change June 27, 2022">Bosentan REMS requirements will change June 27, 2022</a></td> </tr> <tr> <td>4/26/2022</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="fba8d5a2-efd8-4ae2-896f-04b907eab345" href="/drugs/drug-safety-and-availability/fda-alerts-customers-voluntary-recall-compounded-drugs-due-sterility-issues-drug-depot-llc-dba-aps" title="FDA alerts customers to voluntary recall of compounded drugs due to sterility issues by Drug Depot, LLC, dba APS Pharmacy">FDA alerts customers to voluntary recall of compounded drugs due to sterility issues by Drug Depot, LLC, dba APS Pharmacy</a></td> </tr> <tr> <td>4/20/2022</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="a3966ef2-e33c-4394-8cf6-36da109aa0f3" href="/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-artri-and-ortiga-products-which-may-contain-hidden-drug" title="FDA warns consumers not to purchase or use Artri and Ortiga products, which may contain hidden drug ingredients">FDA warns consumers not to purchase or use Artri and Ortiga products, which may contain hidden drug ingredients</a></td> </tr> <tr> <td>3/30/2022</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="32c448f5-8ffb-40d4-bba6-bee2237b2365" href="/drugs/drug-safety-and-availability/fda-warns-patients-and-health-care-professionals-not-use-sterile-products-north-american-custom" title="FDA warns patients and health care professionals not to use sterile products from North American Custom Laboratories LLC, dba FarmaKeio Superior Custom Compounding">FDA warns patients and health care professionals not to use sterile products from North American Custom Laboratories LLC, dba FarmaKeio Superior Custom Compounding</a></td> </tr> <tr> <td>9/17/2021</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="ae6629b5-3816-4103-b333-f03f3a5ac2f8" href="/drugs/drug-safety-and-availability/fda-alerts-patients-and-health-care-professionals-not-use-compounded-products-intended-be-sterile" title="FDA alerts patients and health care professionals not to use compounded products intended to be sterile from Prescription Labs Inc. dba Greenpark Compounding Pharmacy">FDA alerts patients and health care professionals not to use compounded products intended to be sterile from Prescription Labs Inc. dba Greenpark Compounding Pharmacy</a></td> </tr> <tr> <td>7/28/2021</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="3e524d37-0210-4cfc-ba8a-2674f1968aaf" href="/drugs/drug-safety-and-availability/fda-issues-final-decision-withdraw-approval-pepaxto-melphalan-flufenamide" title="FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)">FDA alerts patients and health care professionals about clinical trial results showing an increased risk of death associated with Pepaxto (melphalan flufenamide)</a></td> </tr> <tr> <td>3/19/2021</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="d7c01926-bbdc-4a2e-bba3-b679fd40a166" href="/drugs/drug-safety-and-availability/fda-advises-health-care-professionals-not-use-chloraprep-3-ml-applicators-manufactured-bd-becton" title="FDA advises health care professionals not to use ChloraPrep 3 mL applicators manufactured by BD (Becton, Dickinson and Company)">FDA advises health care professionals not to use ChloraPrep 3 mL applicators manufactured by BD (Becton, Dickinson and Company)</a></td> </tr> <tr> <td>1/15/2021</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="69eba8ad-2c50-4252-a74e-11883f4356bc" href="/drugs/drug-safety-and-availability/fda-updates-vinca-alkaloid-labeling-preparation-intravenous-infusion-bags-only" title="FDA updates vinca alkaloid labeling for preparation in intravenous infusion bags only">FDA updates vinca alkaloid labeling for preparation in intravenous infusion bags only</a></td> </tr> <tr> <td>12/3/2020</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="ec82bcd8-7c6e-446d-a880-884d60e0b5eb" href="/drugs/drug-safety-and-availability/fda-alerts-healthcare-professionals-about-risk-medication-errors-tranexamic-acid-injection-resulting" title="FDA Alerts Healthcare Professionals About the Risk of Medication Errors with Tranexamic Acid Injection Resulting in Inadvertent Intrathecal (Spinal) Injection">FDA alerts healthcare professionals about the risk of medication errors with tranexamic acid injection resulting in inadvertent intrathecal (spinal) injection</a></td> </tr> <tr> <td>9/21/2020</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="ca30ee19-1aab-47a2-b910-d8fad0bd0e04" href="/drugs/drug-safety-and-availability/fda-alerts-perrigos-voluntary-albuterol-inhaler-recall" title="FDA Alerts of Perrigo's voluntary albuterol inhaler recall">FDA alerts of Perrigo's voluntary albuterol inhaler recall</a></td> </tr> <tr> <td>9/8/2020</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="28af1704-90e9-4cc2-a8bd-be2dbd914c53" href="/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-and-oncology-clinical-investigators-about-efficacy-and" title="FDA alerts health care professionals and oncology clinical investigators about efficacy and potential safety concerns with atezolizumab in combination with paclitaxel for treatment of breast cancer ">FDA alerts health care professionals and oncology clinical investigators about efficacy and potential safety concerns with atezolizumab in combination with paclitaxel for treatment of breast cancer </a></td> </tr> <tr> <td>8/14/2020</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="e6d805ea-0d17-442c-8306-eb3e112c7be4" href="/drugs/drug-safety-and-availability/fda-advises-consumers-not-use-goldenseal-root-powder-distributed-maison-terre" title="FDA advises consumers not to use goldenseal root powder distributed by Maison Terre">FDA advises consumers not to use goldenseal root powder distributed by Maison Terre</a></td> </tr> <tr> <td>7/2/2020</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="a1a245e3-3440-4bf8-a42a-1e846175fe51" href="/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use" title="FDA updates on hand sanitizers consumers should not use">FDA warns consumers of risk of methanol contamination in certain hand sanitizers </a></td> </tr> <tr> <td>6/19/2020</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="a6a6e447-d9d5-4eae-8ac0-63392797d495" href="/drugs/drug-safety-and-availability/fda-advises-consumers-not-use-hand-sanitizer-products-manufactured-eskbiochem" title="FDA advises consumers not to use hand sanitizer products manufactured by Eskbiochem">FDA advises consumers not to use hand sanitizer products manufactured by Eskbiochem</a></td> </tr> <tr> <td>6/1/2020</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="2492f140-8124-40ef-875a-20ff04a2454d" href="/drugs/drug-safety-and-availability/fda-alerts-patients-and-health-care-professionals-amneal-and-impax-laboratories-epinephrine-auto" title="FDA alerts patients and health care professionals of Amneal and Impax Laboratories epinephrine auto-injector device malfunctions">FDA alerts patients and health care professionals of Amneal and Impax Laboratories epinephrine auto-injector device malfunctions</a></td> </tr> <tr> <td>3/24/2020</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="5381c326-b8af-4cff-bffc-c2a9c0501b24" href="/drugs/drug-safety-and-availability/fda-alerts-patients-and-health-care-professionals-epipen-auto-injector-errors-related-device" title="FDA alerts patients and health care professionals of EpiPen auto-injector errors related to device malfunctions and user administration">FDA alerts patients and health care professionals of EpiPen auto-injector errors related to device malfunctions and user administration</a></td> </tr> <tr> <td>10/11/2019</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="df1ae7b3-40ce-4cbf-b9ad-dc7320b8d862" href="/drugs/drug-safety-and-availability/fda-advises-consumers-not-use-rompe-pecho-cough-syrup" title="FDA advises consumers not to use Rompe Pecho cough syrup ">FDA advises consumers not to use Rompe Pecho cough syrup</a></td> </tr> <tr> <td>7/23/2019</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="7e4f4a96-7f74-4056-838b-4dc1ac50c7f7" href="/drugs/drug-safety-and-availability/fda-advises-patients-not-use-herbal-doctor-remedies-medicines" title="FDA advises patients not to use Herbal Doctor Remedies’ medicines ">FDA advises patients not to use Herbal Doctor Remedies’ medicines</a></td> </tr> <tr> <td>6/28/2019</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="10c44215-3a25-4ff3-be2e-c7e1738433d9" href="/drugs/drug-safety-and-availability/fda-announces-pacifico-national-incs-dba-amex-pharmacy-voluntary-recall-all-sterile-compounded-drugs" title="FDA announces Pacifico National Inc.’s, dba AmEx Pharmacy, voluntary recall of all sterile compounded drugs">FDA warns patients and health care professionals not to use sterile products from Pacifico National Inc., dba AmEx Pharmacy</a></td> </tr> <tr> <td>6/25/2019</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="65be6361-4574-4d20-bdb4-2d8fd26a8a13" href="/drugs/drug-safety-and-availability/fda-alerts-consumers-not-use-kratom-ncs-products" title="FDA alerts consumers not to use Kratom NC’s products">FDA alerts consumers not to use Kratom NC’s products</a></td> </tr> <tr> <td>6/21/2019</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="ab79e8f4-b6e7-4f21-83fd-2f458aeffa00" href="/drugs/fda-alerts-patients-and-healthcare-professionals-infusion-options-voluntary-recall-due-quality" title="FDA alerts patients and healthcare professionals to Infusion Options’ voluntary recall due to quality issues ">FDA alerts patients and healthcare professionals to Infusion Options’ voluntary recall due to quality issues</a></td> </tr> <tr> <td>2/12/2019</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="ee741405-e2fd-4fdb-b33d-8030b917e004" href="/drugs/drug-safety-and-availability/fda-alerts-patients-mcdaniel-life-lines-voluntary-recall-indian-herb" title="FDA alerts patients of McDaniel Life-Line’s voluntary recall of Indian Herb">FDA alerts patients of McDaniel Life-Line’s voluntary recall of Indian Herb</a></td> </tr> <tr> <td>2/1/2019</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="eabd3f73-1498-4ecd-8167-ae95aa8d2dff" href="/drugs/drug-safety-and-availability/fda-warns-compounders-not-use-glutathione-letco-medical-compound-sterile-drugs" title="FDA warns compounders not to use glutathione from Letco Medical to compound sterile drugs">FDA warns compounders not to use glutathione from Letco Medical to compound sterile drugs</a></td> </tr> <tr> <td>12/11/2018</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="62be99b3-0d0a-4cea-903c-dc5874e0ac2f" href="/drugs/drug-safety-and-availability/fda-alerts-consumers-not-use-two-e-liquids-sold-hellocig-electronic-technology" title="FDA alerts consumers not to use two e-liquids sold by HelloCig Electronic Technology">FDA alerts consumers not to use two e-liquids sold by HelloCig Electronic Technology</a></td> </tr> <tr> <td>12/7/2018</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="f74c71f4-9704-4636-bc4a-22b35e3aa404" href="/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-and-patients-not-use-drug-products-intended-be-sterile-promise" title="FDA alerts health care professionals and patients not to use drug products intended to be sterile from Promise Pharmacy">FDA alerts health care professionals and patients not to use drug products intended to be sterile from Promise Pharmacy</a></td> </tr> <tr> <td>11/19/2018</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="c93815d6-ec6f-4324-9651-100dd845954f" href="/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-and-patients-not-use-sterile-drug-products-pharm-d-solutions" title="FDA alerts health care professionals and patients not to use sterile drug products from Pharm D Solutions">FDA alerts health care professionals and patients not to use sterile drug products from Pharm D Solutions</a></td> </tr> <tr> <td>11/8/2018</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="917c4dfa-7ead-49be-af33-0e05ad4905be" href="/drugs/drug-safety-and-availability/fda-alerts-consumers-kadesh-incorporations-voluntary-nationwide-recall-puriton-eye-relief-drops-due" title="FDA alerts consumers of Kadesh Incorporation’s voluntary nationwide recall of Puriton Eye Relief Drops due to non-sterile production conditions">FDA alerts consumers of Kadesh Incorporation’s voluntary nationwide recall of Puriton Eye Relief Drops due to non-sterile production conditions</a></td> </tr> <tr> <td>11/2/2018</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="f8deb83c-7ec9-4700-b751-19207cc964df" href="/drugs/fda-alerts-patients-and-health-care-professionals-some-epipen-auto-injectors-may-not-readily-slide" title="FDA alerts patients and health care professionals that some EpiPen auto-injectors may not readily slide out of carrier tube">FDA alerts patients and health care professionals that some EpiPen auto-injectors may not readily slide out of carrier tube</a></td> </tr> <tr> <td>10/11/2018</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="0134a360-e06f-4e91-b568-a389ee119fd0" href="/drugs/drug-safety-and-availability/fda-alerts-consumers-sprayologys-voluntary-nationwide-recall-homeopathic-water-based-medicines-due" title="FDA alerts consumers of Sprayology’s voluntary nationwide recall of homeopathic water-based medicines due to microbial contamination "><span class="tablesaw-cell-content">FDA alerts consumers of Sprayology’s voluntary nationwide recall of homeopathic water-based medicines due to microbial contamination </span></a></td> </tr> <tr> <td>10/4/2018</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="71d6f0e0-6b3a-4702-9b21-c04011425ac9" href="/drugs/drug-safety-and-availability/fda-alerts-consumers-and-pet-owners-silver-star-brands-voluntary-recall-homeopathic-drug-products" title="FDA alerts consumers and pet owners of Silver Star Brand’s voluntary recall of homeopathic drug products">FDA alerts consumers and pet owners of Silver Star Brand's voluntary nationwide recall of homeopathic drug products</a></td> </tr> <tr> <td>9/14/2018</td> <td><a href="/drugs/drug-safety-and-availability/fda-alerts-consumers-biolyte-laboratories-voluntary-recall-neorelief">FDA alerts consumers of BioLyte Laboratories voluntary recall of NeoRelief</a></td> </tr> <tr> <td>9/14/2018</td> <td><a href="/drugs/drug-safety-and-availability/fda-alerts-consumers-not-use-products-distributed-years-your-health">FDA alerts consumers not to use products distributed by Years to Your Health</a></td> </tr> <tr> <td>9/7/2018</td> <td><a href="/drugs/drug-safety-and-availability/fda-alerts-consumers-beaumont-bio-meds-voluntary-recall-all-water-and-alcohol-based-products">FDA alerts consumers of Beaumont Bio Med's voluntary recall of all water and alcohol-based products</a></td> </tr> <tr> <td>8/31/2018</td> <td><a href="/drugs/drug-safety-and-availability/fda-alerts-consumers-hellolifes-voluntary-recall-neuroveen-respitrol-thyroveev-and-compulsin">FDA alerts consumers of HelloLife's voluntary recall of Neuroveen, Respitrol, Thyroveev and Compulsin</a></td> </tr> <tr> <td>8/17/2018</td> <td><a href="/drugs/drug-safety-and-availability/fda-alerts-drug-makers-recall-porcine-thyroid-api-sichuan-friendly-pharmaceutical-co-limited-china">FDA alerts drug makers of a recall of porcine thyroid API from Sichuan Friendly Pharmaceutical Co., Limited, China</a></td> </tr> <tr> <td>7/10/2018</td> <td><a href="/drugs/drug-safety-and-availability/fda-announces-raniers-rx-laboratorys-voluntary-recall-all-sterile-compounded-drug">FDA announces Ranier's Rx Laboratory voluntary recall of all sterile compounded drug</a></td> </tr> <tr> <td>7/5/2018</td> <td><a href="/drugs/drug-safety-and-availability/fda-advises-consumers-not-use-blissful-remedies-kratom-products-due-bacterial-contamination">FDA advises consumers not to use Blissful Remedies kratom products due to bacterial contamination</a></td> </tr> <tr> <td>6/29/2018</td> <td><a href="/drugs/drug-safety-and-availability/fda-advises-health-care-professionals-not-use-medgyn-products-monsels-solution">FDA advises health care professionals not to use MedGyn Products Monsel's Solution</a></td> </tr> <tr> <td>5/30/2018</td> <td><a href="/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-patients-and-drug-supply-chain-not-use-stolen-fertility-drugs">FDA alerts health care professionals, patients, and the drug supply chain not to use stolen fertility drugs, Gonal-f RFF Redi-ject and Gonal-f Multi-Dose</a></td> </tr> <tr> <td>4/13/2018</td> <td><a href="/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-voluntary-nationwide-recall-all-sterile-products-coastal-meds">FDA alerts health care professionals to voluntary nationwide recall of all sterile products from Coastal Meds</a></td> </tr> <tr> <td>3/30/2018</td> <td><a href="/drugs/drug-safety-and-availability/fda-alerts-consumers-nationwide-voluntary-recall-topical-drug-products-made-industria-farmaceutica">FDA alerts consumers of a nationwide voluntary recall of topical drug products made by Industria Farmacéutica Andrómaco due to contamination</a></td> </tr> <tr> <td>3/16/2018</td> <td><a href="/drugs/drug-safety-and-availability/fda-alerts-consumers-bayers-voluntary-recall-alka-seltzer-plus-products-due-labeling-errors">FDA is alerting consumers of a voluntary recall of Bayer's Alka-Seltzer Plus products due to labeling errors</a></td> </tr> <tr> <td>3/16/2018</td> <td><a href="/drugs/drug-safety-and-availability/fda-warns-consumers-not-use-unapproved-erectile-dysfunction-products-advertised-radio">FDA warns consumers not to use unapproved erectile dysfunction products advertised on the radio</a></td> </tr> <tr> <td>1/12/2018</td> <td><a href="/drugs/drug-safety-and-availability/fda-notifies-health-care-professionals-becton-dickinson-replaced-problematic-rubber-stoppers-its">FDA notifies health care professionals that Becton-Dickinson replaced problematic rubber stoppers in its syringes</a></td> </tr> <tr> <td>10/27/2017</td> <td><a href="/drugs/drug-safety-and-availability/fda-updates-2017-burkholderia-cepacia-contamination">FDA updates on 2017 Burkholderia cepacia contamination</a></td> </tr> <tr> <td>9/1/2017</td> <td><a href="/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-and-patients-not-use-alcohol-pads-or-benzalkonium-chloride">FDA alerts health care professionals and patients not to use alcohol pads or benzalkonium chloride antiseptic towelettes manufactured by Foshan Flying Medical Products</a></td> </tr> <tr> <td>8/21/2017</td> <td><a href="/drugs/drug-safety-and-availability/fda-warns-consumers-about-health-risks-herbal-coffee-products-malaysia-containing-undeclared-active">FDA warns consumers about health risks of herbal coffee products from Malaysia containing undeclared active pharmaceutical ingredients and milk</a></td> </tr> <tr> <td>8/10/2017</td> <td><a href="/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-and-patients-not-use-sterile-drug-products-vital-rx-dba">FDA alerts health care professionals and patients not to use sterile drug products from Vital Rx, dba Atlantic Pharmacy and Compounding</a></td> </tr> <tr> <td>7/28/2017</td> <td><a href="/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-adverse-events-associated-guardians-compounded-triamcinolone">FDA alerts health care professionals of adverse events associated with Guardian's compounded triamcinolone and moxifloxacin product for intravitreal injection</a></td> </tr> <tr> <td>10/12/2016</td> <td><a href="/drugs/drug-safety-and-availability/fda-updates-multistate-outbreak-burkholderia-cepacia-infections">FDA updates on multistate outbreak of burkholderia cepacia Infections</a></td> </tr> <tr> <td>5/12/2016</td> <td><a href="/drugs/drug-safety-and-availability/fda-advises-health-care-professionals-counterfeit-bicnu-has-been-discovered-some-foreign-countries">FDA advises health care professionals that counterfeit BiCNU has been discovered in some foreign countries</a></td> </tr> <tr> <td>4/15/2016</td> <td><a href="/drugs/drug-safety-and-availability/fda-announces-pharmakon-pharmaceuticals-nationwide-voluntary-recall-purportedly-sterile-drug">FDA alerts health care professionals not to use sterile drug products from Pharmakon Pharmaceuticals, Inc., Noblesville, Indiana</a></td> </tr> <tr> <td>4/15/2016</td> <td><a href="/drugs/drug-safety-and-availability/fda-issues-three-new-draft-guidances-related-compounding-human-drugs">FDA issues three new draft guidances related to compounding of human drugs</a></td> </tr> <tr> <td>4/1/2016</td> <td><a href="/drugs/drug-safety-and-availability/fda-alert-fda-alerts-health-care-professionals-and-patients-not-use-sterile-drug-products-medaus">FDA alerts health care professionals and patients not to use sterile drug products from Medaus Pharmacy, Birmingham, Alabama</a></td> </tr> <tr> <td>3/30/2016</td> <td><a href="/drugs/drug-safety-and-availability/fda-announces-voluntary-recall-all-unexpired-human-and-animal-compounded-drug-products-produced">FDA announces voluntary recall of all unexpired compounded drug products produced by Reliable Rexall, San Francisco</a></td> </tr> <tr> <td>3/23/2016</td> <td><a href="/drugs/drug-safety-and-availability/fda-warns-consumers-not-use-best-bentonite-clay">FDA warns consumers not to use "Best Bentonite Clay" laboratory tests indicate elevated levels of lead </a></td> </tr> <tr> <td>3/14/2016</td> <td><a href="/drugs/drug-safety-and-availability/fda-alerts-healthcare-professionals-about-clinical-trials-zydelig-idelalisib-combination-other">FDA alerts healthcare professionals about clinical trials with Zydelig (idelalisib) in combination with other cancer medicines</a></td> </tr> <tr> <td>3/9/2016</td> <td><a href="/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-and-patients-not-use-human-and-animal-sterile-drug-products">FDA alerts health care professionals and patients not to use human and animal sterile drug products produced and distributed by I.V. Specialty, Ltd., Austin, Texas</a></td> </tr> <tr> <td>2/16/2016</td> <td><a href="/drugs/drug-safety-and-availability/fda-announces-pharmakon-pharmaceuticals-voluntary-recall-morphine-sulfate-05-mgml-preservative-free">FDA announces Pharmakon Pharmaceuticals voluntary recall of morphine sulfate 0.5 mg/mL preservative free in 0.9% sodium chloride</a></td> </tr> <tr> <td>2/10/2016</td> <td><a href="/drugs/drug-safety-and-availability/fda-alerts-compounding-pharmacies-nationwide-voluntary-recall-syrspend-sf-and-syrspend-sf-grape">FDA alerts compounding pharmacies of a nationwide voluntary recall of Syrspend SF and Syrspend SF Grape suspending agents from Fagron Inc., due to microbial contamination with yeast</a></td> </tr> <tr> <td>1/28/2016</td> <td><a href="/drugs/drug-safety-and-availability/fda-warns-consumers-about-health-risks-alikay-naturals-bentonite-me-baby-bentonite-clay">FDA warns consumers about health risks with Alikay Naturals - Bentonite Me Baby - Bentonite Clay</a></td> </tr> <tr> <td>1/28/2016</td> <td><a href="/drugs/drug-safety-and-availability/fda-warns-consumers-not-use-viansilks-crema-piel-de-seda-silky-skin-cream">FDA warns consumers not to use Viansilk's "Crema Piel De Seda" ("Silky Skin Cream")</a></td> </tr> <tr> <td>1/15/2016</td> <td><a href="/drugs/drug-safety-and-availability/fda-warns-consumers-not-use-licorice-coughing-liquid">FDA warns consumers not to use Licorice Coughing Liquid</a></td> </tr> <tr> <td>3/2/2018</td> <td><a href="/drugs/drug-safety-and-availability/fda-working-manufacturers-withdraw-zinbryta-market-united-states">FDA working with manufacturers to withdraw Zinbryta from the market in the United States</a></td> </tr> </tbody> </table> </div> <h2><a id="statements" name="statements"></a>Statements</h2> <p>Learn about CDER's work to enhance public health</p> <div class="lcds-datatable lcds-datatable--ckeditor"> <table class="table table-striped table-border" data-column-defs="[{ "targets": 0, "type": "date" }]" data-excel-button="true" data-order="[ 0, "desc" ]" data-paging="true" data-searching="true" summary="Drug Alerts and Statements"> <thead> <tr> <th scope="col">Date</th> <th scope="col" style="width: 80%;">Title</th> </tr> </thead> <tbody> <tr> <td>10/31/2024</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="8209272a-d3af-4c7d-9c1b-90624ed2d034" href="/drugs/drug-safety-and-availability/fda-approves-rems-modification-advancing-new-drug-disposal-option" title="FDA approves REMS modification, advancing new drug disposal option">FDA approves REMS modification, advancing new drug disposal option</a></td> </tr> <tr> <td>10/02/2024</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="c0e084af-268f-4b83-8187-4ea7226ce408" href="/drugs/drug-safety-and-availability/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize" title="FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize">FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize</a></td> </tr> <tr> <td>9/24/2024</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="5a2b1a3d-61cb-455c-8cbd-aa5c5f4c55a9" href="/drugs/drug-safety-and-availability/fdas-istand-pilot-program-accepts-submission-first-organ-chip-technology-designed-predict-human-drug" title="FDA's ISTAND Pilot Program accepts a submission of first organ-on-a-chip technology designed to predict human drug-induced liver injury (DILI)">FDA's ISTAND Pilot Program accepts a submission of first organ-on-a-chip technology designed to predict human drug-induced liver injury (DILI)</a></td> </tr> <tr> <td>6/20/2024</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="b8b48019-39df-4400-9f7c-0935481b5b79" href="/drugs/drug-safety-and-availability/fda-updates-guidance-interchangeability" title="FDA updates guidance on interchangeability">FDA updates guidance on interchangeability</a></td> </tr> <tr> <td>6/14/2024</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="7365d41c-9677-499f-823d-b92f4130112c" href="/drugs/drug-safety-and-availability/fda-issues-agency-initiated-proposed-order-regarding-otc-monograph-drugs-containing-acetaminophen" title="FDA issues agency-initiated proposed order regarding OTC monograph drugs containing acetaminophen">FDA issues agency-initiated proposed order regarding OTC monograph drugs containing acetaminophen</a></td> </tr> <tr> <td>4/15/2024</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="dba722f4-b255-4dc3-91e2-29fe3cad4b32" href="/drugs/drug-safety-and-availability/fda-establishes-cder-center-clinical-trial-innovation-c3ti" title="FDA establishes CDER Center for Clinical Trial Innovation (C3TI)">FDA establishes CDER Center for Clinical Trial Innovation (C3TI)</a></td> </tr> <tr> <td>3/25/2024</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="6f5c0abd-5368-438f-8661-3f48b23155fa" href="/drugs/drug-safety-and-availability/cder-establishes-new-quantitative-medicine-center-excellence" title="CDER Establishes New Quantitative Medicine Center of Excellence ">CDER Establishes New Quantitative Medicine Center of Excellence</a></td> </tr> <tr> <td>3/15/2024</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="fae94c06-8903-4324-aa5a-4b2f0ab431c6" href="/drugs/drug-safety-and-availability/fda-announces-new-quality-oversight-webpage" title="FDA Announces New Quality Oversight Webpage">FDA Announces New Quality Oversight Webpage</a></td> </tr> <tr> <td>3/11/2024</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="96d76644-a832-473a-a2aa-f3b12c76ec66" href="/drugs/drug-safety-and-availability/fda-issues-guidance-regarding-drug-development-early-alzheimers-disease" title="FDA issues guidance regarding drug development for early Alzheimer’s disease ">FDA issues guidance regarding drug development for early Alzheimer’s disease</a></td> </tr> <tr> <td>1/29/2024</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="2ff7a5bf-81b6-4e08-ab47-27e65c73f4ff" href="/drugs/drug-safety-and-availability/fda-revises-letter-authorization-emergency-use-authorization-paxlovid" title="FDA revises letter of authorization for the emergency use authorization for Paxlovid">FDA revises letter of authorization for the emergency use authorization for Paxlovid</a></td> </tr> <tr> <td>1/23/2024</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="74aad2c6-c28e-4aac-a4d5-fac1270869d3" href="/drugs/drug-safety-and-availability/fdas-istand-pilot-program-accepts-submission-first-artificial-intelligence-based-and-digital-health" title="FDA's ISTAND Pilot Program accepts submission of first artificial intelligence-based and digital health technology for neuroscience">FDA's ISTAND Pilot Program accepts submission of first artificial intelligence-based and digital health technology for neuroscience</a></td> </tr> <tr> <td>12/21/2023</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="ee60a2b1-4db3-4248-89e3-bdfbb144fb3d" href="/drugs/drug-safety-and-availability/fda-warns-consumers-not-use-counterfeit-ozempic-semaglutide-found-us-drug-supply-chain" title="FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain">FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain</a></td> </tr> <tr> <td>12/15/2023</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="6868ef08-b83b-4a1c-b35f-31602b5edbad" href="/drugs/drug-safety-and-availability/fda-approves-safety-labeling-changes-opioid-pain-medicines" title="FDA approves safety labeling changes for opioid pain medicines">FDA approves safety labeling changes for opioid pain medicines</a></td> </tr> <tr> <td>10/17/2023</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="b79e8df4-a7b0-4c3c-8e85-ffe47dc6f108" href="/drugs/drug-safety-and-availability/cder-soliciting-comments-regarding-clinical-trial-innovation" title="CDER soliciting comments regarding clinical trial innovation">CDER soliciting comments regarding clinical trial innovation</a></td> </tr> <tr> <td>9/21/2023</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="7a3468aa-07c9-4db4-9eae-57fa70927a57" href="/drugs/drug-safety-and-availability/fda-issues-guidance-using-remote-oversight-tools-help-approve-drugs" title="FDA issues guidance on using remote oversight tools to help approve drugs">FDA issues guidance on using remote oversight tools to help approve drugs</a></td> </tr> <tr> <td>9/18/2023</td> <td><a data-entity-substitution="canonical" 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authorizes Gohibic (vilobelimab) injection for the treatment of COVID-19 ">FDA authorizes Gohibic (vilobelimab) injection for the treatment of COVID-19</a></td> </tr> <tr> <td>3/29/2023</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="da919bb3-df1c-4d79-a5e8-b93d0e871792" href="/drugs/drug-safety-and-availability/fda-launches-lupus-treatment-consortium-partnership-lupus-research-alliance" title="FDA launches Lupus Treatment Consortium in partnership with the Lupus Research Alliance">FDA launches Lupus Treatment Consortium in partnership with the Lupus Research Alliance</a></td> </tr> <tr> <td>1/20/2023</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="669627c6-ef4d-4c76-a87d-de868311792a" href="/drugs/drug-safety-and-availability/fda-issues-guidance-help-increase-supply-ibuprofen-oral-suspension-products-hospitals-and-health" title="FDA issues guidance to help increase supply of ibuprofen oral suspension products in hospitals and health systems">FDA issues guidance to help increase supply of ibuprofen oral suspension products in hospitals and health systems</a></td> </tr> <tr> <td>11/30/2022</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="9b5888f9-2b41-4a0d-a11b-f6bf811c37a9" href="/drugs/drug-safety-and-availability/fda-announces-bebtelovimab-not-currently-authorized-any-us-region" title="FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region ">FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region</a></td> </tr> <tr> <td>11/4/2022</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="064e967c-c5fe-402f-9fc4-bff79e4871be" href="/drugs/drug-safety-and-availability/fda-updates-bebtelovimab" title="FDA Updates on Bebtelovimab ">FDA Updates on Bebtelovimab</a></td> </tr> <tr> <td>10/21/2022</td> <td><a data-entity-substitution="canonical" data-entity-type="node" 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data-entity-type="node" data-entity-uuid="f7537071-f292-453c-9bdc-537609812d99" href="/drugs/drug-safety-and-availability/fda-launches-new-resource-provide-easily-accessible-more-accurate-historical-drug-approval-data" title="FDA launches new resource to provide easily accessible, more accurate historical drug approval data">FDA launches new resource to provide easily accessible, more accurate historical drug approval data</a></td> </tr> <tr> <td>1/31/2010</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="f9725b98-4f7f-4a0d-b72f-e5bf5ca308f2" href="/drugs/drug-safety-and-availability/fda-requests-withdrawal-bacitracin-injection-market" title="FDA requests withdrawal of bacitracin for injection from market ">FDA requests withdrawal of bacitracin for injection from market</a></td> </tr> <tr> <td>1/30/2020</td> <td><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="9ffb2e40-efb6-4688-9398-680cf1d3b4c0" 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href="/drugs/drug-safety-and-availability/fda-warns-about-risks-associated-investigational-use-venclexta-multiple-myeloma" title="FDA Warns about the risks associated with the investigational use of Venclexta in Multiple Myeloma">FDA warns about the risks associated with the investigational use of Venclexta in Multiple Myeloma</a></td> </tr> <tr> <td>9/26/2018</td> <td><a href="/drugs/drug-safety-and-availability/fda-announces-new-and-expanded-compounding-research-projects">FDA announces new and expanded compounding research projects</a></td> </tr> <tr> <td>9/20/2018</td> <td><a href="/drugs/drug-safety-and-availability/fda-analysis-finds-no-new-or-unexpected-safety-risks-associated-nuplazid-pimavanserin-medication">FDA analysis finds no new or unexpected safety risks associated with Nuplazid (pimavanserin), a medication to treat the hallucinations and delusions of Parkinson's disease psychosis</a></td> </tr> <tr> <td>7/18/2018</td> <td><a href="/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-angiotensin-ii-receptor-blocker-arb-recalls-valsartan-losartan">FDA updates and press announcements on angiotensin II receptor blocker (ARB) recalls (Valsartan, Losartan, and Irbesartan)</a></td> </tr> <tr> <td>6/28/2018</td> <td><a href="/drugs/drug-safety-and-availability/cder-statement-fda-approves-labeling-supplement-celebrex-celecoxib">FDA approves labeling supplement for Celebrex (celecoxib)</a></td> </tr> <tr> <td>6/21/2018</td> <td><a href="/drugs/drug-safety-and-availability/fda-withdraws-draft-guidance-industry-statistical-approaches-evaluate-analytical-similarity">FDA withdraws draft guidance for industry: Statistical Approaches to Evaluate Analytical Similarity</a></td> </tr> <tr> <td>5/22/2018</td> <td><a href="/drugs/drug-safety-and-availability/fda-video-series-about-biosimilar-and-interchangeable-products">FDA video series about biosimilar and interchangeable products</a></td> </tr> <tr> <td>5/18/2018</td> <td><a href="/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-and-oncology-clinical-investigators-about-efficacy-issue">FDA alerts health care professionals and oncology clinical investigators about an efficacy issue identified in clinical trials for some patients taking Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as monotherapy to treat urothelial cancer with low expression of PD-L1</a></td> </tr> <tr> <td>5/16/2018</td> <td><a href="/drugs/drug-safety-and-availability/fda-reports-quality-problems-data-provided-firm-iqvia-were-used-inform-estimates-some-controlled">FDA reports quality problems for data provided by the firm IQVIA that were used to inform estimates for some controlled substances</a></td> </tr> <tr> <td>3/14/2018</td> <td><a href="/drugs/drug-safety-and-availability/fda-working-manufacturers-withdraw-zinbryta-market-united-states">FDA working with manufacturers to withdraw Zinbryta from the market in the United States</a></td> </tr> <tr> <td>12/14/2017</td> <td><a href="/drugs/drug-safety-and-availability/fda-reminds-pharmaceutical-industry-new-drug-listing-certification-requirement-due-december-31-2017">FDA reminds pharmaceutical industry of new drug listing certification requirement due December 31, 2017</a></td> </tr> <tr> <td>11/14/2017</td> <td><a href="/drugs/drug-safety-and-availability/fda-works-help-relieve-iv-fluid-shortages-wake-hurricane-maria">FDA works to help relieve the IV fluid shortages in wake of Hurricane Maria</a></td> </tr> <tr> <td>9/8/2017</td> <td><a href="/drugs/drug-safety-and-availability/fda-warns-meridian-medical-technologies-about-cgmp-violations-associated-manufacture-epipen">FDA warns Meridian Medical Technologies about CGMP violations associated with the manufacture of EpiPen</a></td> </tr> <tr> <td>8/31/2017</td> <td><a href="/drugs/drug-safety-and-availability/fda-alerts-healthcare-professionals-and-oncology-clinical-investigators-about-two-clinical-trials">FDA alerts healthcare professionals and oncology clinical investigators about two clinical trials on hold evaluating KEYTRUDA® (pembrolizumab) in patients with multiple myeloma</a></td> </tr> <tr> <td>8/4/2017</td> <td><a href="/drugs/drug-safety-and-availability/fda-warns-consumers-not-use-balguti-kesaria-ayurvedic-medicine-due-high-levels-lead">FDA warns consumers not to use Balguti Kesaria Ayurvedic Medicine due to high levels of lead</a></td> </tr> <tr> <td>6/20/2017</td> <td><a href="/drugs/drug-safety-and-availability/fda-issues-warning-about-body-building-products-labeled-contain-steroid-and-steroid-substances">FDA issues warning about body-building products labeled to contain steroid and steroid-like substances</a></td> </tr> <tr> <td>5/22/2017</td> <td><a href="/drugs/drug-safety-and-availability/fda-advises-drug-manufacturers-burkholderia-cepacia-complex-poses-contamination-risk-non-sterile">FDA advises drug manufacturers that Burkholderia cepacia complex poses a contamination risk in non-sterile, water-based drug product</a></td> </tr> <tr> <td>4/13/2017</td> <td><a href="/drugs/drug-safety-and-availability/fda-announces-standard-homeopathic-companys-nationwide-voluntary-recall-hylands-teething-tablets">FDA announces Standard Homeopathic Company's nationwide voluntary recall of Hyland's teething tablets</a></td> </tr> <tr> <td>1/17/2017</td> <td><a href="/drugs/drug-safety-and-availability/fda-approves-generic-xyrem-rems-program">FDA approves a generic of Xyrem with a REMS Program</a></td> </tr> <tr> <td>1/12/2017</td> <td><a href="/drugs/drug-safety-and-availability/fda-issues-final-guidance-repackaging-and-revised-draft-guidance-mixing-diluting-and-repackaging">FDA issues final guidance on repackaging and revised draft guidance on mixing, diluting, and repackaging biological products</a></td> </tr> <tr> <td>1/10/2017</td> <td><a href="/drugs/drug-safety-and-availability/fda-warns-cancer-patients-not-use-pnc-27-products-treatment">FDA warns cancer patients not to use PNC-27 products for treatment</a></td> </tr> <tr> <td>1/9/2017</td> <td><a href="/drugs/drug-safety-and-availability/impact-exclusivity-approval-arymo-er">Impact of exclusivity on approval of Arymo ER</a></td> </tr> <tr> <td>12/28/2016</td> <td><a href="/drugs/drug-safety-and-availability/fda-issues-guidance-prescription-requirement-under-section-503a">FDA issues guidance on prescription requirement under section 503A</a></td> </tr> <tr> <td>12/28/2016</td> <td><a href="/drugs/drug-safety-and-availability/fda-issues-draft-guidances-compounding-and-repackaging-radiopharmaceuticals">FDA issues draft guidances on compounding and repackaging radiopharmaceuticals</a></td> </tr> <tr> <td>12/15/2016</td> <td><a href="/drugs/drug-safety-and-availability/fda-proposes-six-bulk-drug-substances-inclusion-503a-bulks-list">FDA proposes six bulk drug substances for inclusion on the 503A bulks list</a></td> </tr> <tr> <td>10/25/2016</td> <td><a href="/drugs/drug-safety-and-availability/fda-approves-new-changes-testosterone-labeling-regarding-risks-associated-abuse-and-dependence">FDA approves new changes to testosterone labeling regarding the risks associated with abuse and dependence of testosterone and other anabolic androgenic steroids (AAS)</a></td> </tr> <tr> <td>10/17/2016</td> <td><a href="/drugs/drug-safety-and-availability/proposed-rule-amend-list-drug-products-may-not-be-compounded-because-they-have-been-withdrawn-or">Proposed rule to amend the list of drug products that may not be compounded because they have been withdrawn or removed from the market for safety and effectiveness reasons</a></td> </tr> <tr> <td>10/11/2016</td> <td><a href="/drugs/drug-safety-and-availability/fda-analyses-conclude-xarelto-clinical-trial-results-were-not-affected-faulty-monitoring-device">FDA analyses conclude that Xarelto clinical trial results were not affected by faulty monitoring device</a></td> </tr> <tr> <td>10/6/2016</td> <td><a href="/drugs/drug-safety-and-availability/final-rule-amending-list-drug-products-may-not-be-compounded-because-they-have-been-withdrawn-or">Final rule amending list of drug products that may not be compounded because they have been withdrawn or removed from the market for safety or effectiveness reasons</a></td> </tr> <tr> <td>8/12/2016</td> <td><a href="/drugs/drug-safety-and-availability/fda-finds-drugs-under-investigation-us-related-french-bia-10-2474-drug-do-not-pose-similar-safety">FDA finds drugs under investigation in the U.S. related to French BIA 10-2474 drug do not pose similar safety risks</a></td> </tr> <tr> <td>8/3/2016</td> <td><a href="/drugs/drug-safety-and-availability/fda-issues-draft-guidance-insanitary-conditions-compounding-facilities">FDA issues draft guidance on insanitary conditions at compounding facilities</a></td> </tr> <tr> <td>7/8/2016</td> <td><a href="/drugs/drug-safety-and-availability/fda-approves-dedicated-syringe-be-used-humulin-r-u-500-insulin">FDA approves a dedicated syringe to be used with Humulin R U-500 insulin</a></td> </tr> <tr> <td>7/7/2016</td> <td><a href="/drugs/drug-safety-and-availability/fda-issues-proposals-implement-statutory-restrictions-compounding-drugs-are-essentially-copies">FDA issues proposals to implement statutory restrictions on compounding drugs that are essentially copies of commercially available or approved drugs</a></td> </tr> <tr> <td>6/9/2016</td> <td><a href="/drugs/drug-safety-and-availability/update-fda-revises-final-guidances-interim-policy-certain-bulk-drug-substances-used-compounding">FDA issues final guidances on interim policy for certain bulk drug substances used in compounding</a></td> </tr> <tr> <td>5/26/2016</td> <td><a href="/drugs/drug-safety-and-availability/neonatal-opioid-withdrawal-syndrome-and-medication-assisted-treatment-methadone-and-buprenorphine">Neonatal opioid withdrawal syndrome and medication-assisted treatment with methadone and buprenorphine</a></td> </tr> <tr> <td>3/15/2016</td> <td><a href="/drugs/drug-safety-and-availability/fda-warns-consumers-about-potential-risks-using-eye-drops-packaged-bottles-loose-safety-seals">FDA warns consumers about potential risks of using eye drops packaged in bottles with loose safety seals</a></td> </tr> <tr> <td>1/22/2016</td> <td><a href="/drugs/drug-safety-and-availability/fda-finds-drugs-under-investigation-us-related-french-bia-10-2474-drug-do-not-pose-similar-safety">FDA works with regulatory partners to understand French-based Biotrial phase 1 clinical study</a></td> </tr> </tbody> <tbody> <tr> <td> </td> </tr> </tbody> </table> </div> <h2>Archived Alerts and Statements 2010-2015</h2> <ul> <li><a href="https://wayback.archive-it.org/7993/20170111070736/http://www.fda.gov/Drugs/DrugSafety/ucm215175.htm">FDA Archive 2014-2015</a></li> <li><a href="http://web.archive.org/web/20140206163935/http://www.fda.gov/Drugs/DrugSafety/ucm215175.htm">FDA Archive 2010-2013</a> </li> </ul> </div>   </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top"> <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Content current as of:</h2> <p class="lcds-description-list__item-text"><time datetime="2024-11-01T00:00:00Z">11/01/2024</time> </p> </div> </li> <li role="menuitem" class="lcds-description-list__item"> <div> 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