LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia Malta NDC 0591-3745-00
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lots 1207344A, exp. date 06/2020; 1207343A, 1207342A, exp. date 07/2020
- 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:
- Teva Pharmaceuticals USA
- Reason for Recall:
- CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia Malta NDC 0591-3745-00
Product Codes/Lot Numbers:
Lots 1207344A, exp. date 06/2020; 1207343A, 1207342A, exp. date 07/2020
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1100-2020
Related Recalls
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
CGMP Deviations: use of an unapproved raw material