Recalls / Class II

Class IID-1140-2018

Product

Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-207-30

Affected lot / code info

Batch: BV53D004, BV53C006, BV53D001, BV53D002, BV53D003, BV53C004, BV53C005

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

78144 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-1140-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.