Overview of recall records associated with Amneal Pharmaceuticals, Inc., including dates, categories and classifications where available.
Classification mix: Class III: 5, Class II: 1.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
This page summarizes recall records in which the official source identifies Amneal Pharmaceuticals, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
