Category
FDA recalls of prescription and over-the-counter drugs.
FDA drug recalls cover prescription medicines, over-the-counter products, biologic and gene therapies, and active pharmaceutical ingredients (the raw drug substances that manufacturers compound into finished products). Recall classifications follow the same Class I / II / III system as food, and most published recalls are Class II — the product is unlikely to cause permanent harm but doesn't meet specification.
The most common reasons for a drug recall are out-of-specification potency or dissolution (the active ingredient is present in too high or too low a dose), microbial contamination, particulate matter in injectables, mix-ups during packaging where bottles end up with the wrong tablets, and nitrosamine impurities in certain drug classes. Many drug recalls are at the lot level — the manufacturer's whole product line is still safe to use, but specific production lots are pulled.
If a recall affects your medication: don't stop taking it on your own. Call your prescriber or pharmacist before doing anything. Stopping a prescribed drug abruptly can be more dangerous than the issue prompting the recall. Most drug-recall remedies route through the dispensing pharmacy, who'll either swap your supply for an unaffected lot or coordinate a refund with the manufacturer.
Accord Healthcare is recalling Allopurinol 100 mg tablets due to the presence of a small piece of green plastic embedded in some tablets. The plastic poses a potential choking and ingestion hazard.
Pharmacy Innovations is recalling Tobramycin Fortified 15mg/mL Ophthalmic Solution nationwide due to insanitary facility conditions that compromised sterility assurance. Consumers should discontinue use and contact their healthcare provider.
The FDA has recalled Methotrexate intravitreal injectable from Pharmacy Innovations due to lack of assured sterility. An FDA inspection revealed insanitary conditions at the manufacturing facility.
Pharmacy Innovations is recalling Ketamine 50mg/ml injectable vials nationwide due to insanitary facility conditions that compromised sterility assurance.
Pharmacy Innovations is recalling Mitomycin ophthalmic solutions nationwide due to a lack of sterility assurance. An FDA inspection found insanitary conditions at the manufacturing facility.
Pharmacy Innovations is recalling Clindamycin/EDTA Calcium irrigation solution (30ML syringe) distributed nationwide due to lack of assurance of sterility caused by insanitary conditions found during FDA inspection.
Pharmacy Innovations is recalling Minoxidil 0.75% injectable due to insanitary facility conditions identified during FDA inspection that could compromise product sterility.
Pharmacy Innovations recalls Cholecalciferol (Vitamin D3) 100,000U/ML Injectable nationwide due to insanitary conditions at the manufacturing facility that compromise product sterility assurance.
Pharmacy Innovations is recalling Edetate Calcium Disodium 400MG/ML injectable vials nationwide due to insanitary manufacturing conditions that compromise sterility assurance.
Pharmacy Innovations is recalling Flurbiprofen 0.04% ophthalmic solution nationwide due to insanitary conditions at the manufacturing facility that compromise product sterility.
Pharmacy Innovations is recalling Acetylcysteine 10% Ophthalmic Solution nationwide due to FDA-identified insanitary manufacturing conditions that compromise product sterility. Affected batches include codes t20221011@36 and t20221108@24.
Pharmacy Innovations is recalling nationwide Albuterol 0.083% inhalation solution in 3ML tubes due to insanitary manufacturing facility conditions that compromise sterility assurance.
Pharmacy Innovations is recalling an injectable medication due to lack of sterility assurance caused by insanitary conditions at the manufacturing facility. Affected vials were distributed nationwide.
Pharmacy Innovations recalls two concentrations of atropine sulfate eye drops due to insanitary facility conditions discovered by FDA inspection. The products were distributed nationwide.
Pharmacy Innovations is recalling Hydroxocobalamin 25MG/ML injectable vials nationwide due to insanitary facility conditions identified during FDA inspection that compromise sterility assurance.
FDA is recalling BSS Plus/Lidocaine Opth 1% injectable syringes manufactured by Pharmacy Innovations due to lack of sterility assurance found during a facility inspection.
Pharmacy Innovations is recalling multiple glutathione products due to insanitary facility conditions that compromise sterility assurance. The recall affects inhalation and injectable formulations distributed nationwide.
Pharmacy Innovations is recalling 5-Fluorouracil 1% ophthalmic solution nationwide due to lack of sterility assurance. An FDA inspection found insanitary conditions at the manufacturing facility.
Pharmacy Innovations is recalling Cyclosporine ophthalmic solutions (0.1%, 0.2%, 1%, 2%, and corn-oil-based 1%) due to lack of sterility assurance. FDA inspection found insanitary facility conditions.
Pharmacy Innovations is recalling Glycerin Sterile 99% Injectable (2ML and 5ML vials) nationwide. FDA inspection revealed insanitary facility conditions that compromise the product's sterility assurance.
LEVEMIR injectable insulin is being recalled nationwide due to insanitary facility conditions that compromise sterility assurance. FDA inspection identified conditions that may affect product safety.
Ascend Laboratories recalls 49,632 bottles of Metoprolol Succinate extended-release tablets (25 mg) nationwide and in Puerto Rico due to failure to meet dissolution specifications that could reduce drug effectiveness.
Pharmacy Innovations is recalling injectable methylcobalamin products in multiple strengths due to lack of sterility assurance. FDA inspection revealed insanitary facility conditions that compromise product safety.
Pharmacy Innovations is recalling injectable glycerin/lidocaine/epinephrine products nationwide due to lack of sterility assurance. FDA inspection found insanitary conditions at the manufacturing facility.
Pharmacy Innovations has recalled Chlorpheniramine/Hyoscyamine injectable medication nationwide due to insanitary facility conditions identified during FDA inspection that compromise product sterility.
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