Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC 43547-0369-09. Tablet is yellow, capsule-shaped, biconvex, film-coated tablets debossed with 343 on one side and HH on the other side.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # VSA000OV Manufacturer's original lot # 343B17015, exp date 02/19 NDC 43547-0369-09
- 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:
- H J Harkins Company Inc dba Pharma Pac
- Reason for Recall:
- Carcinogen impurity detected in API used to manufacture drug product.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC 43547-0369-09. Tablet is yellow, capsule-shaped, biconvex, film-coated tablets debossed with 343 on one side and HH on the other side.
Product Codes/Lot Numbers:
Lot # VSA000OV Manufacturer's original lot # 343B17015, exp date 02/19 NDC 43547-0369-09
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1022-2018
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