Why it was recalled
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.
Lot numbers, UPCs & expiration codes
Lot #s: UV1004, UV1005, Exp 6/22; UW1014, UW1015, Exp 1/23; UW1084, Exp 7/23
Where it was sold
Nationwide USA and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0713-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 21, 2022
- FDA report date
- Mar 9, 2022
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Morton Grove Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0713-2022, exactly as published.
Show all FDA fields
- City
- Morton Grove
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 89624
- Address
- 6451 Main St
- Code information
- Lot #s: UV1004, UV1005, Exp 6/22; UW1014, UW1015, Exp 1/23; UW1084, Exp 7/23
- Postal code
- 60053-2633
- Report date
- Mar 9, 2022
- Product type
- Drugs
- Recall number
- D-0713-2022
- Classification
- Class II
- Recalling firm
- Morton Grove Pharmaceuticals, Inc.
- Termination date
- Aug 6, 2024
- Reason for recall
- Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide USA and Puerto Rico
- Recall initiation date
- Feb 21, 2022
- Initial firm notification
- Letter
- Center classification date
- Mar 21, 2022