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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

American Health Valproic Acid Oral Solution Recalled for Contamination

Agency Publication Date: September 24, 2021
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Summary

American Health Packaging has issued a voluntary recall for 548 cases of Valproic Acid Oral Solution (500 mg/10 mL), a prescription medication used to treat seizures. The recall was initiated due to concerns that batches of liquid sugar used in manufacturing may have been contaminated with microbial organisms. No illnesses or injuries related to this issue have been reported to date. The affected products were distributed to pharmacies and healthcare providers nationwide.

Risk

The use of an oral medication contaminated with microorganisms can lead to serious infections, especially in patients with compromised immune systems. Because this product is used to manage seizure disorders, any compromise in product quality could pose a significant health risk to consumers.

What You Should Do

  1. This recall affects American Health Packaging Valproic Acid Oral Solution, USP (500 mg/10 mL) packaged in cases of 100 unit-dose cups (10 mL each).
  2. Identify affected products by looking for lot number 1000082 with an expiration date of 06/30/2022.
  3. Check the packaging for Case NDC number 60687-262-56 or Individual Dose NDC number 60687-262-42.
  4. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Valproic Acid Oral Solution, USP (500 mg/10 mL)
Variants: 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only
Lot Numbers:
1000082 (Exp 06/30/2022)
NDC:
60687-262-56
60687-262-42

548 cases affected. Packaged and Distributed by American Health Packaging, Columbus, Ohio.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88696
Status: Resolved
Manufacturer: American Health Packaging
Sold By: pharmacies; healthcare providers
Manufactured In: United States
Units Affected: 548 ccases
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.