Home / Recalls / Torrent Pharma Inc. / D-1142-2018

D-1142-2018 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: 50,784 bottles

Product Description

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-326-30

Reason for Recall

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

Distribution Pattern

Nationwide USA

Code Information

Batch: BBY1E001, BBY1E003, BBY1C002, BBY1E002, BBY1D001

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