Class II Recall

Shilpa Medicare Limited

Product
PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2453-1
Reason
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Classification
Class II
Status
Ongoing
Lot
Lot: P400172; Lot PA00050A, Exp 09/30/2027
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.