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.
Tailor Made Compounding is recalling Levocarnitine 500mg/mL vials nationwide due to lack of sterility assurance, a Class II FDA recall.
Tailor Made Compounding is recalling Biotin 5mg/mL injections distributed nationwide and in Puerto Rico because the manufacturer cannot assure the products were sterilized according to FDA standards.
Tailor Made Compounding is recalling 180 vials of BCAA (branched-chain amino acid) injections nationwide due to inability to assure the product maintained sterility. Affected batches expire between April and June 2022.
Tailor Made Compounding recalls 39 vials of a compounded injectable product for lack of assurance of sterility. Distribution was nationwide in the USA and Puerto Rico.
Tailor Made Compounding is recalling 1,856 vials of NAD+ 200mg/mL because the company cannot assure the product meets sterility requirements. The affected vials were distributed nationwide to the United States and Puerto Rico.
Tailor Made Compounding recalls 41 vials of Testosterone Cypionate/Anastrozole due to lack of assured sterility. FDA Class II recall affects products distributed nationwide.
Tailor Made Compounding is recalling 243 vials of Nandrolone Decanoate injectable medication due to lack of sterility assurance. The affected product was distributed nationwide in the USA and Puerto Rico.
TMC Acquisition LLC is recalling specific batches of Hydroxocobalamin Preservative Free injectable due to lack of sterility assurance. The affected vials were distributed nationwide in the USA and Puerto Rico.
A compounded sermorelin/glycine injectable has been recalled because the manufacturer cannot assure the product is sterile. The recall affects approximately 2,870 vials distributed nationwide.
Tailor Made Compounding is recalling Procaine HCL 2% injectable solution due to lack of sterility assurance. The recall affects 58 vials distributed nationwide.
TMC Acquisition LLC is recalling Testosterone Cypionate injectable vials (100mg/ml) due to lack of assurance of sterility. The recall affects 273 vials distributed nationwide in the USA and Puerto Rico.
Tailor Made Compounding is recalling 60 GOAL injectable vials nationwide due to lack of sterility assurance, which may pose a contamination risk.
Jubilant Draximage Inc. is recalling Draximage MAA, an injectable diagnostic drug kit, due to failed endotoxin testing. The recall affects 519 cartons distributed nationwide (Lot 1H005, expiration November 30, 2023).
Tailor Made Compounding is recalling 93 vials of Testosterone Enanthate due to lack of assurance of sterility. The affected batches were distributed nationwide and in Puerto Rico.
Tailor Made Compounding recalled 9,993 vials of compounded semaglutide/cyanocobalamin due to lack of assurance of sterility. No illnesses have been reported.
Tailor Made Compounding recalls 349 vials of Estradiol Cypionate 10mg/mL due to lack of assurance of sterility. The product was distributed nationwide in the USA and Puerto Rico.
Tailor Made Compounding is recalling 294 vials of Gonadorelin 100mcg/mL distributed nationwide because the manufacturer cannot assure the product meets sterility standards.
Tailor Made Compounding is recalling Vitamin B-Complex Preservative Free injectable vials (batch 03112233B) nationwide due to lack of assurance of sterility. The product should not be used.
Tailor Made Compounding recalls 84 vials of Dexpanthenol Preservative Free due to lack of assurance of sterility. The medication was distributed nationwide and in Puerto Rico.
Tailor Made Compounding is recalling Vitamin B-Complex injectable vials (10 mL and 30 mL) distributed nationwide USA and Puerto Rico due to lack of assurance of sterility.
Tailor Made Compounding is recalling 232 vials of Methionine/Inositol/Choline B12 injectable across the U.S. and Puerto Rico due to lack of assurance of sterility. Patients who received this medication should contact their healthcare provider.
Tailor Made Compounding is recalling 652 vials of Methylcobalamin 10mg/mL injectable due to lack of assurance of sterility. No illnesses or injuries have been reported.
Tailor Made Compounding is recalling 1,208 vials of Sermorelin due to inability to assure sterility. The product was distributed nationwide in the USA and Puerto Rico across multiple batch lots.
Tailor Made Compounding is recalling 19 vials of Dexpanthenol 250mg/mL due to lack of assurance of sterility. Two batches with different expiration dates were distributed nationwide in the USA and Puerto Rico.
Tailor Made Compounding is recalling 90 vials of GAC (Glutamine/Arginine/L-Carnitine) injectable solution distributed nationwide and in Puerto Rico due to lack of assurance of sterility.
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