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.