Losartan Potassium recalled over manufacturing violations
- Recall date
- June 14, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Golden State Medical Supply Inc. recalls Losartan Potassium, 50 mg tablets, 90 count bottle, NDC 60429-317-90
- Recall number
- D-1463-2019
- FDA classification
- Class II
- Brand / firm
- Golden State Medical Supply Inc.
- Sold / distributed
- US Nationwide One (1) US government account. No foreign accounts.
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Losartan Potassium, 50 mg tablets, 90 count bottle, NDC 60429-317-90
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