LOSARTAN POTASSIUM TABLETS recalled over manufacturing violations
- Recall date
- December 20, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Torrent Pharma Inc. recalls LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmace…
- Recall number
- D-0503-2019
- 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 an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
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, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
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