Recalls / Class II
Class IID-1463-2019
Product
Losartan Potassium, 50 mg tablets, 90 count bottle, NDC 60429-317-90
- Affected lot / code info
- Lot #: GS017651, Expiration 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
- Golden State Medical Supply Inc.
- Type
- Voluntary: Firm initiated
- Address
- 5187 Camino Ruiz, Camarillo, California 93012-8601
Distribution
- Quantity
- 14,955 bottles (1,345,950 tablets)
- Distribution pattern
- US Nationwide One (1) US government account. No foreign accounts.
Timeline
- Recall initiated
- 2019-06-14
- FDA classified
- 2019-07-09
- Posted by FDA
- 2019-07-17
- Terminated
- 2020-02-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1463-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.