Amlodipine recalled over manufacturing violations
- Recall date
- August 17, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Torrent Pharma Inc. recalls Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufac…
- Recall number
- D-1144-2018
- FDA classification
- Class II
- Brand / firm
- Torrent Pharma Inc.
- Sold / distributed
- Nationwide USA
Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-328-30
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