Recalls / Class II
Class IID-1138-2018
Product
Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-205-30
- Affected lot / code info
- Batch: BV84D010, BV84E001, BV84C011, BV84D001, BV84D002, BV84D005, BV84D006, BV84D007, BV84D008, BV84D009, BV84C006, BV84C007, BV84C008, BV84C009
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
- 66864 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-1138-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.