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.
Denver Solutions recalls 6,276 IV bags of oxytocin due to a labeling defect. The product was distributed nationwide to healthcare facilities.
Denver Solutions is recalling 33,480 Vancomycin HCI IV bags (NDC 71449-028-68) due to a labeling issue. The affected lots were distributed nationwide.
West-Ward Columbus Inc is recalling Methotrexate Sodium 2.5 mg tablets because some tablets have unsmooth surfaces and illegible identification markings. The recall affects 2,673 cartons distributed to MS and OH.
Denver Solutions, LLC is recalling 25,908 Vancomycin HCI IV bags distributed nationwide due to a labeling issue. Affected lots include products with expiration dates from October 2023 through January 2024.
FDA recalls TheraBreath for Kids Oral Rinse due to microbial contamination identified as Candida parapsilosis yeast. Approximately 5,316 bottles distributed nationwide are affected.
VistaPharm is recalling 180 bottles of Sucralfate Oral Suspension nationwide due to Bacillus cereus contamination, a Class I recall. The affected lot (810300, expiring October 2023) should not be used.
KVK-Tech's Betaxolol Hydrochloride tablets (10 mg, lot 17853A) are being recalled nationwide due to potential contamination with oxycodone tablets. Patients should stop using affected bottles immediately and contact their healthcare provider.
Pine Pharmaceuticals is recalling 860 syringes of intranasal lidocaine-oxymetazoline solution distributed nationwide due to lack of sterility assurance. Lot 67808 expired 10/23/2023.
Pine Pharmaceuticals recalls Tropi-Phen ophthalmic solution due to lack of sterility assurance. The 15 mL droppers were distributed nationwide and customers should not use affected lots.
Pine Pharmaceuticals recalls Calcium Chloride IV Solution for Intravenous Injection, 20 mg/mL (lot 70101), due to lack of assurance of sterility. Approximately 130 units were distributed nationwide.
Baxter Healthcare is recalling 472 vials of Doxil chemotherapy medication due to exposure to temperatures exceeding labeled storage conditions during transportation. Affected vials were distributed nationwide.
Pine Pharmaceuticals has recalled 662 dropper units of Tropi-Phen ophthalmic solution due to lack of sterility assurance. The affected lots were distributed nationwide.
Pine Pharmaceuticals is recalling TPC Drops ophthalmic solution due to lack of assurance of sterility. The recall affects 1693 droppers distributed nationwide.
Pine Pharmaceuticals is recalling 4,972 syringes of Cefuroxime injectable medication due to lack of assurance of sterility. The compounded antibiotic was distributed nationwide.
Pine Pharmaceuticals is recalling 2,484 syringes of Moxifloxacin intraocular injection nationwide due to lack of sterility assurance in the compounded product.
Pine Pharmaceuticals recalls 2,176 syringes of compounded moxifloxacin nationwide due to inadequate sterility assurance. The product was distributed to healthcare providers and patients.
Pine Pharmaceuticals is recalling Lidocaine HCl 4% ophthalmic solution due to lack of sterility assurance. The affected product was distributed nationwide in 1,598 single-use droppers.
Pine Pharmaceuticals is recalling Calcium Gluconate Ophthalmic Irrigation Solution 1% (Lot #69802) due to lack of sterility assurance. The 128 bags distributed nationwide may pose infection risk if used.
Pine Pharmaceuticals is recalling 9,673 vials of compounded lidocaine-phenylephrine injectable due to lack of assurance of sterility. Affected lots were distributed nationwide.
Pine Pharmaceuticals is recalling Calcium Gluconate 2.5% inhalation solution due to lack of sterility assurance. Patients should stop using affected syringes and contact their healthcare provider.
Pine Pharmaceuticals is recalling Foscarnet Sodium 2.4mg/0.1 mL injectable syringes nationwide due to lack of assurance of sterility. No illnesses or injuries have been reported.
Pine Pharmaceuticals recalled an Endophth Kit (Vancomycin/Ceftazidime injectable) distributed nationwide due to lack of assurance of sterility. The recall affects 201 kits from lot 69986 (expires 11/15/2023).
Pine Pharmaceuticals is recalling 26 vials of Vancomycin 1 MG/0.1 ML intraocular injection (Lot #69985) due to lack of assurance of sterility. The product was distributed nationwide.
Pine Pharmaceuticals is recalling approximately 2,862 syringes of compounded Bevacizumab 1.25 MG/0.05 ML Solution for Injection due to lack of assurance of sterility. The product was distributed nationwide.
Sun Pharmaceutical is recalling Bupropion Hydrochloride Extended-Release Tablets (150 mg), lot HAD0360A, due to failed dissolution specifications. The 144 bottles were distributed nationwide and may not dissolve at the intended rate.
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