22 recalls · Class III, newest first
Reason Sub-Potent Drug: Subpotent assay results during stability testing.
Reason Presence of foreign tablets/capsules
Reason Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Reason Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established…
Reason Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Reason Cross contamination with other products
Reason Cross contamination with other products
Reason Labeling: Wrong Barcode
Reason Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Reason Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Reason Failed Dissolution Specifications
Reason Cross contamination with other products
Reason Failed dissolution specifications: below specification results at stability 12-month
Reason Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Reason Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Reason Labeling: Missing label: the product tube was missing a label and contained a different formulation.
Reason Subpotent Drug; Ethinyl Estradiol
Reason Subpotent Drug; Ethinyl Estradiol
Reason Subpotent Drug; Ethinyl Estradiol
Reason Subpotent Drug; Ethinyl Estradiol
Reason Subpotent Drug; Ethinyl Estradiol
Reason Crystallization; Complaints that cream appears to have crystallized