Recalls / Class II
Class IID-0713-2022
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.
- Affected lot / code info
- Lot #s: UV1004, UV1005, Exp 6/22; UW1014, UW1015, Exp 1/23; UW1084, Exp 7/23
Why it was recalled
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Recalling firm
- Firm
- Morton Grove Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 6451 Main St, Morton Grove, Illinois 60053-2633
Distribution
- Distribution pattern
- Nationwide USA and Puerto Rico
Timeline
- Recall initiated
- 2022-02-21
- FDA classified
- 2022-03-21
- Posted by FDA
- 2022-03-09
- Terminated
- 2024-08-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0713-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.