Losartan Potassium/ Hydrochlorothiazide Tablets recalled over manufacturing violations
- Recall date
- September 19, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Torrent Pharma Inc. recalls Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torr…
- Recall number
- D-0124-2020
- 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 of 9.82 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/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-118-90
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