Home / Recalls / Torrent Pharma Inc. / D-1143-2018

D-1143-2018 Class II Ongoing

Recalled by Torrent Pharma Inc. — Basking Ridge, NJ

Recall Details

Product Type: Drugs
Report Date: September 5, 2018
Initiation Date: August 17, 2018
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 22704 bottles

Product Description

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-327-30

Reason for Recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Distribution Pattern

Nationwide USA

Code Information

Batch: BBY2E001, BBY2D001, BBY2D002

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