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.
The FDA is recalling Cefepime for Injection 2 grams per vial due to inability to assure product sterility. No illnesses have been reported.
Apollo Care is recalling Norepinephrine 4 mg dextrose injection (682 bags) due to lack of assurance of sterility. Distribution was limited to Missouri.
Meitheal Pharmaceuticals is recalling Ampicillin and Sulbactam for Injection nationwide due to lack of assurance of sterility. No illnesses have been reported.
Apollo Care, LLC is recalling 1,113 bags of Vancomycin 1.25g injection in 250 mL of 0.9% Sodium Chloride solution due to lack of assurance of sterility. The recall affects product distributed in Missouri.
Astral SteriTech Private Ltd. is recalling 9,040 bottles of Ceftriaxone for Injection (10 gram pharmacy bulk packages) nationwide due to lack of assurance of sterility. All affected lots remain within expiration dates.
Astral SteriTech is recalling 101,550 vials of Cefepime for Injection nationwide because sterility assurance cannot be confirmed.
Astral SteriTech is recalling 964,420 vials of Cefepime for Injection due to lack of sterility assurance. The medication was distributed nationwide.
Vancomycin 1.5g in 0.9% saline solution being recalled due to lack of assurance of sterility. Product distributed in Missouri with lot numbers AC-016629 and AC-016646.
Piramal Critical Care is recalling Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, due to lack of sterility assurance. The nationwide recall affects approximately 112,640 vials.
Ampicillin and Sulbactam for Injection is being recalled nationwide due to lack of assurance of sterility. Approximately 58,770 vials manufactured by Astral SteriTech Private Ltd. are affected.
Astral SteriTech is recalling 17,350 vials of Ampicillin for Injection nationwide because the manufacturer cannot assure the product's sterility. Healthcare providers and patients should consult their healthcare provider about exposure.
Apollo Care, LLC is recalling Succinylcholine Cl Injection due to lack of sterility assurance. The affected lot was distributed in Missouri.
Apollo Care, LLC is recalling VANComycin 1.75 g injectable solution (NDC 71170-194-50) due to lack of assurance of sterility. The recall affects 240 bags distributed in Missouri.
Astral SteriTech recalls approximately 393,930 vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assurance of sterility, per FDA Class II classification.
Apollo Care's VANComycin 750mg injectable lacks assurance of sterility. The 491 bags distributed in Missouri are being recalled due to potential contamination risk.
FDA recalls Ampicillin and Sulbactam for Injection (1.5 grams per vial) manufactured by Astral SteriTech due to lack of sterility assurance. The recall affects 236,610 vials distributed nationwide.
RemedyRepack Inc. is recalling 9,038 vials of Lorazepam Injection due to discontinuation of the manufacturer's quality control program. The product may not meet specified identity, strength, quality, and purity standards.
The FDA is recalling 169,520 vials of Piperacillin and Tazobactam injectable antibiotic due to lack of assurance of sterility. The affected vials were distributed nationwide.
Astral SteriTech is recalling approximately 138,610 vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assurance of sterility.
Apollo Care, LLC is recalling 1,617 bags of Norepinephrine 8 mg intravenous injection distributed in Missouri due to lack of assurance that the product meets sterility requirements.
Apollo Care, LLC is recalling VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The recall affects 1,622 bags distributed in Missouri.
Ampicillin for Injection is being recalled by Xellia Pharmaceuticals because the manufacturer cannot assure the vials are sterile. The nationwide recall involves 220,340 vials.
Ampicillin for Injection (500 mg/vial) is being recalled nationwide due to inability to assure sterility. The recall covers approximately 59,530 vials.
FDA recalls 66,175 vials of Ceftriaxone for Injection (500 mg) nationwide due to lack of sterility assurance. Patients and healthcare providers should consult regarding appropriate action.
Ampicillin and Sulbactam for Injection vials are being recalled nationwide due to lack of assurance of sterility. Approximately 91,860 vials of this prescription antibiotic have been affected.
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