Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-127-91
Reason
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Classification
Class III
Status
Ongoing
Lot
Lot #: 550167301, 550167401, Exp. Date NOV-25; 550185101, Exp. Date MAR-26; 550205701, Exp. Date JUL-26
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Endo USA, Inc. — Class III Recall | MedicineWatch US