Recalls / Class II

Class IID-1144-2018

Product

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-328-30

Affected lot / code info

Batch: BBX9D004, BBX9E001, BBX9D001, BBX9D002, BBX9D003

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

34320 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-1144-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.