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.
Recall Number: D-0713-2022
Firm: Morton Grove Pharmaceuticals, Inc.
Classification: Class II
Status: Terminated
Report Date: 20220309
Initiation Date: 20220221
Termination Date: 20240806
Reason for Recall
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Product Description
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.