Class II
Ongoing
Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-206-30
This recall is currently active, issued September 5, 2018. It was issued by Torrent Pharma Inc..
- Company
- Torrent Pharma Inc.
- Recall Initiated
- August 17, 2018
- Posted
- September 5, 2018
- Recall Number
- D-1139-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 46272 bottles
- Firm Location
- Basking Ridge, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Distribution
Nationwide USA
Lot / Code Info
Batch: BV65D002, BV65C002, BV65C003, BV65C004, BV65D001
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