Why it was recalled
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Product description
Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-621-16
Lot numbers, UPCs & expiration codes
Lot #: UV1159
Where it was sold
Nationwide USA and China
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-0816-2021
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Sep 3, 2021
- FDA report date
- Sep 29, 2021
- Quantity
- 38,748 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Morton Grove Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0816-2021, exactly as published.
Show all FDA fields
- City
- Morton Grove
- State
- IL
- Status
- Completed
- Country
- United States
- Event ID
- 88629
- Address
- 6451 Main St
- Code information
- Lot #: UV1159
- Postal code
- 60053-2633
- Report date
- Sep 29, 2021
- Product type
- Drugs
- Recall number
- D-0816-2021
- Classification
- Class II
- Recalling firm
- Morton Grove Pharmaceuticals, Inc.
- Product quantity
- 38,748 bottles
- Reason for recall
- CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-621-16
- Distribution pattern
- Nationwide USA and China
- Recall initiation date
- Sep 3, 2021
- Initial firm notification
- Letter
- Center classification date
- Sep 20, 2021