Recalls / Class II
Class IID-1270-2019
Product
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.
- Affected lot / code info
- Lot #: B0517068-101618, Exp. Date: 10/2019
Why it was recalled
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.
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, N/A, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 44 HDPE bottles of 90 = 3,960 tablets
- Distribution pattern
- Product was distributed to Florida.
Timeline
- Recall initiated
- 2019-04-22
- FDA classified
- 2019-05-02
- Posted by FDA
- 2019-05-08
- Terminated
- 2020-05-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1270-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.