Drug 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.
D-0713-2022
Product summary
- Event
- Event 89624
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0713-2022
Official wording
Reason: Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Code information: Lot #s: UV1004, UV1005, Exp 6/22; UW1014, UW1015, Exp 1/23; UW1084, Exp 7/23
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications