Class II
Ongoing
LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3746-00
This recall is currently active, issued April 15, 2020. It was issued by Teva Pharmaceuticals Usa.
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- March 25, 2020
- Posted
- April 15, 2020
- Recall Number
- D-1101-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Parsippany, NJ, United States
- Official Source
- View on FDA website ↗
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.
Distribution
Bulk product was distributed to one re-packager in California.
Lot / Code Info
Lots 1195625A, 1195624A, 1195623A, exp. date 03/2020
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