Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Major Label Unit Does 10 x 10 Cartons, Major Item # 301835. Lot Number: R-00474. Expiration date: 07/2019.
- 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:
- MAJOR PHARMACEUTICALS
- Reason for Recall:
- CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152.
Product Codes/Lot Numbers:
Major Label Unit Does 10 x 10 Cartons, Major Item # 301835. Lot Number: R-00474. Expiration date: 07/2019.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1466-2019
Related Recalls
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Failed Dissolution Specifications
Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.