Losartan Potassium Tablets recalled over manufacturing violations
- Recall date
- April 18, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Torrent Pharma Inc. recalls Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)1000-count (NDC: 13668-409-10) per bottle, R…
- Recall number
- D-1265-2019
- FDA classification
- Class II
- Brand / firm
- Torrent Pharma Inc.
- Sold / distributed
- Nationwide USA and Puerto Rico
Why it was recalled
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
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 Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)1000-count (NDC: 13668-409-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
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