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.
Astral SteriTech is recalling approximately 138,610 vials of Piperacillin and Tazobactam for Injection nationwide due to lack of assurance of sterility.
Apollo Care's fentanyl 50 mcg/mL injectable syringes are recalled due to lack of assurance of sterility. The 790-syringe batch distributed in Missouri may pose contamination risks if administered.
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.
Astral SteriTech is recalling Ceftriaxone for Injection due to lack of assurance of sterility. The Class II recall affects approximately 7,940 pharmacy bulk packages distributed nationwide.
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.
Apollo Care's VANComycin 750mg injectable lacks assurance of sterility. The 491 bags distributed in Missouri are being recalled due to potential contamination risk.
Apollo Care is recalling Ketamine Injection single-use syringes (2,040 units) distributed in Missouri due to lack of assurance of sterility. Patients should consult their healthcare provider if affected.
Astral SteriTech is recalling 59,040 vials of Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. The product was distributed nationwide.
Apollo Care LLC is recalling 1,113 bags of VANComycin injectable solution due to lack of assurance of sterility. The recalled product was distributed in Missouri.
Astral SteriTech is recalling approximately 66,250 vials of Ceftriaxone for Injection due to lack of sterility assurance. The injectable antibiotic poses a potential contamination risk if used.
Ceftriaxone for Injection is being recalled nationwide due to lack of assurance of sterility. Approximately 73,475 vials manufactured by Astral SteriTech may not meet required sterility standards.
Astral SteriTech is recalling Ampicillin and Sulbactam for Injection due to inability to assure product sterility. Approximately 357,550 vials distributed nationwide; no illnesses have been reported.
RemedyRepack Inc. is recalling Ketotifen Fumarate eye drops (NDC 70518-1142-00) distributed in Pennsylvania due to the manufacturer's discontinuation of quality assurance programs, which may have affected product identity, strength, and purity.
Apollo Care, LLC is recalling 2,265 syringes of PHENYLephrine HCl Injection (100 mcg/mL) due to lack of assurance of sterility. The affected lots were distributed in Missouri only.
Astral SteriTech recalls approximately 893,950 vials of piperacillin and tazobactam injection nationwide because the manufacturer cannot assure the product was properly sterilized.
Astral SteriTech is recalling approximately 110,660 vials of Piperacillin and Tazobactam for Injection due to lack of assurance of sterility. The product was distributed nationwide.
Astral SteriTech's 66,125-vial ceftriaxone injection is being recalled nationwide due to lack of assurance of sterility in manufacturing. The product is distributed across the United States.
Apollo Care, LLC is recalling 413 bags of Vancomycin 2g injectable solution (Lot #AC-016638, expiration 05/27/2023) distributed in Missouri due to lack of assurance of sterility.
Ampicillin for Injection, 250 mg per vial (NDC 70594-084-02) is recalled nationwide due to lack of assurance of sterility. The recall affects 53,220 vials manufactured by Astral SteriTech Private Ltd.
Ampicillin and Sulbactam for Injection recalled nationwide due to failure to assure sterility. Over 1 million vials affected; patients should not use recalled units.
Astral SteriTech Private Ltd. is recalling Ampicillin for Injection due to manufacturing controls that cannot assure product sterility. The FDA Class II recall affects approximately 80,850 vials distributed nationwide.
The FDA is recalling Ampicillin and Sulbactam for Injection due to lack of assurance of sterility. The medication was distributed nationwide within the United States.
Astral SteriTech is recalling approximately 89,690 vials of Ampicillin for Injection due to lack of assurance of sterility. The product was distributed nationwide.
Ampicillin and Sulbactam for Injection is being recalled nationwide because the manufacturer cannot assure sterility of 591,160 vials distributed throughout the United States.
Apollo Care is recalling Norepinephrine 4 mg dextrose injection (682 bags) due to lack of assurance of sterility. Distribution was limited to Missouri.
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