Class II
Terminated
Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by RemedyRepack, Inc. Indiana, PA, 15701-3570, NDC 70518-1560-00.
- Company
- Remedyrepack Inc.
- Recall Initiated
- April 22, 2019
- Posted
- May 8, 2019
- Recall Number
- D-1270-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 44 HDPE bottles of 90 = 3,960 tablets
- Firm Location
- Indiana, PA, 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 0.96 parts per million.
Distribution
Product was distributed to Florida.
Lot / Code Info
Lot #: B0517068-101618, Exp. Date: 10/2019
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