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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot 1000082; Exp 06/30/2022
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- American Health Packaging
- Reason for Recall:
- CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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
Product Codes/Lot Numbers:
Lot 1000082; Exp 06/30/2022
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0854-2021
Related Recalls
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Subpotent Drug: Out of specification for assay.
Impurity failure at 0-time of the repackaged lot.