FDAFDA · Food and drugs·Recall number D-1458-2019
Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-44
Published July 17, 2019 · Recall initiated: June 20, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- LOSARTAN POTASSIUM
- Manufacturer
- Macleods Pharma Usa Inc
- Distributor
- Nationwide
- Lot
- BLI710A Nov 2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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