Recalls / Class II
Class IID-1455-2019
Product
LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00
- Affected lot / code info
- Arrow Malta (Teva) Bulk Product Lot # 1169752A, exp. date 01/2020, 1000 tablets/bottle 1169753A, exp. date 01/2020, 90 tablets/bottle Golden State Medical Finished Product Lot # GS017387, exp. date 01/2020 GS017651, exp. date 01/2020 GS017479, 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
- 2,924,000 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-1455-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.