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Research, guidelines, and safety alerts for your specialty.
Recent updates in Rheumatology from the last 30 days.
The FDA classified a Class II recall for Mylan Pharmaceuticals' Mycophenolate Mofetil for Injection, USP, 500 mg/vial (NDC 67457-386-81 and 67457-386-00), citing failed dissolution specifications. The affected product includes cartons of 4 single-dose vials manufactured in India for Mylan Institutional LLC.
Apotex Corp. issued a Class II recall for Paxil CR (Paroxetine) Extended-Release Tablets, 37.5mg, 30-count bottles, NDC 60505-4379-3. The recall notice states the product failed to meet dissolution specifications and did not meet 24-month stability testing acceptance criteria.
Lupin Pharmaceuticals is recalling its Clobetasol Propionate Cream USP, 0.05%, 60 g tube (NDC 68180-956-04) in a Class II recall. The recall was issued because the product failed content uniformity specifications, according to the recall notice.
Mallinckrodt Hospital Products Inc. issued a Class II recall of Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vials, NDC 63004-8710-1 and 63004-8710-2. The recall notice states the reason is presence of particulate matter, identified as glass and stopper piece, within the vials.
Fresenius Kabi USA has issued a Class I recall of Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, NDC 65219-594-20. The recall states that an internal investigation at the firm found the product to contain glass particulate matter.
