Recalls / Class II
Class IID-1134-2018
Product
Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-068-90
- Affected lot / code info
- Batch: BV46C007, BV46C008, BV46C009, BV46C010, BV46C011, BV46C012, BV46C003, BV46C006
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
- 24468 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-1134-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.