FDA Recall D-1140-2018
Torrent Pharma Inc. · Basking Ridge, NJ
Class II Ongoing 2827 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recall record
- Recall number
D-1140-2018- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide USA
- Recall initiated
- 2018-08-17
- Classified by FDA Center
- 2018-08-28
- FDA published
- 2018-09-05
- Recalling firm
- Torrent Pharma Inc.
- Firm location
- Basking Ridge, NJ
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.