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.

FDA recall notice · announced March 9, 2022 · Morton Grove Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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 for recall

Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.

Notes

Distribution: Nationwide USA and Puerto Rico
Lot/code information: Lot #s: UV1004, UV1005, Exp 6/22; UW1014, UW1015, Exp 1/23; UW1084, Exp 7/23
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.