Class II
Ongoing
Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-409-10
- Company
- Torrent Pharma Inc.
- Recall Initiated
- September 19, 2019
- Posted
- October 9, 2019
- Recall Number
- D-0121-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 8,688 bottles
- Firm Location
- Basking Ridge, NJ, United States
Reason for Recall
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
Distribution
Nationwide USA and Puerto Rico
Lot / Code Info
Lot 4DU2E009
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