Class II Recall

Morton Grove Pharmaceuticals, Inc.

Product
Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-466-08.
Reason
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Classification
Class II
Status
Terminated
Lot
Lot #s: UV1004, UV1005, Exp 6/22; UW1014, UW1015, Exp 1/23; UW1084, Exp 7/23
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