Class II Recall

Morton Grove Pharmaceuticals, Inc.

Product
Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-608-16
Reason
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Classification
Class II
Status
Completed
Lot
Lot #: UV1335; UV1352; and UV1373
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.
Morton Grove Pharmaceuticals, Inc. — Class II Recall | MedicineWatch US