D-0713-2022 Class II Terminated
FDA drug recall D-0713-2022 was initiated by Morton Grove Pharmaceuticals, Inc. on February 21, 2022 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product. The recall status is terminated (terminated August 6, 2024).
Recall Details
- Product Type
- Drugs
- Report Date
- March 9, 2022
- Initiation Date
- February 21, 2022
- Termination Date
- August 6, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
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.
Reason for Recall
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Distribution Pattern
Nationwide USA and Puerto Rico
Code Information
Lot #s: UV1004, UV1005, Exp 6/22; UW1014, UW1015, Exp 1/23; UW1084, Exp 7/23