Class II
Ongoing
LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00
This recall is currently active, issued July 17, 2019. It was issued by Teva Pharmaceuticals Usa.
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- June 6, 2019
- Posted
- July 17, 2019
- Recall Number
- D-1456-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2,943,000 tablets
- 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
Nationwide by 4 major distributors.
Lot / Code Info
Arrow Malta (Teva) Bulk Product Lot # 1163892A, exp. date 01/2020 1163893A, exp. date 01/2020 1163894A, exp. date 01/2020 1163895A, exp. date 01/2020 Golden State Medical Finished Product Lot # GS017042, exp. date 01/2020 GS017043, exp. date 01/2020 GS017044, exp. date 01/2020 GS017541, exp. date 01/2020
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