Recalls / Class II
Class IID-1142-2018
Product
Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-326-30
- Affected lot / code info
- Batch: BBY1E001, BBY1E003, BBY1C002, BBY1E002, BBY1D001
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
- 50,784 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-1142-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.