Home / Recalls / Torrent Pharma Inc. / D-1137-2018

D-1137-2018 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
89616 bottles

Product Description

Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-204-30

Reason for Recall

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

Distribution Pattern

Nationwide USA

Code Information

Batch: BV77D013, BV77C011, BV77D001, BV77D002, BV77D003, BV77D004, BV77D005, BV77D006, BV77D007, BV77D008, BV77D009 , BV77D010, BV77D011, BV77D012, BV77C009, BV77C010

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