Recalls / Class II

Class IID-1135-2018

Product

Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-069-90

Affected lot / code info

Batch: BV47C005, BV47C006, BV47D001, BV47C003, BV47C004

Why it was recalled

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

Recalling firm

Firm

Torrent Pharma Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

150 Allen Rd Ste 102, N/A, Basking Ridge, New Jersey 07920-3856

Distribution

Quantity

14016 bottles

Distribution pattern

Nationwide USA

Timeline

Recall initiated

2018-08-17

FDA classified

2018-08-28

Posted by FDA

2018-09-05

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-1135-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.