Recalls / Class II
Class IID-1456-2019
Product
LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00
- Affected 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
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.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 2,943,000 tablets
- Distribution pattern
- Nationwide by 4 major distributors.
Timeline
- Recall initiated
- 2019-06-06
- FDA classified
- 2019-07-09
- Posted by FDA
- 2019-07-17
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1456-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.