7 recalls · Class III, newest first
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Cross contamination with other products
Cross contamination with other products
Labeling: Wrong Barcode
Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.