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, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 Case NDC#: 60687-262-56; Individual Dose NDC: 60687-262-42
Lot numbers, UPCs & expiration codes
Lot 1000082; Exp 06/30/2022
Where it was sold
Nationwide USA
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-0854-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 15, 2021
- FDA report date
- Oct 6, 2021
- Quantity
- 548 ccases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-0854-2021, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 88696
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot 1000082; Exp 06/30/2022
- Postal code
- 43217-1188
- Report date
- Oct 6, 2021
- Product type
- Drugs
- Recall number
- D-0854-2021
- Classification
- Class II
- Recalling firm
- American Health Packaging
- Product quantity
- 548 ccases
- Termination date
- Jun 8, 2023
- 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, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 Case NDC#: 60687-262-56; Individual Dose NDC: 60687-262-42
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Sep 15, 2021
- Initial firm notification
- Letter
- Center classification date
- Sep 24, 2021