Reported Apr 15, 2020 · Ongoing
LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only,…
Teva Pharmaceuticals USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA · 400 Interpace Pkwy · Parsippany, NJ · 07054-1120
Is this the product you have?
- LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only
- Manufactured byArrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3747-00
- Lot codes and dates
1178533A1178534A1178535A1178536A1178537A1178538A1178539A1178540A1178541A1178542A1178543A1178544A1178545A1178546A exp 03/2020
- Amount recalled
- N/A
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
This product could cause temporary or reversible health problems — stop using it.
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