Recalls / Class II
Class IID-0032-2021
Product
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90
- Affected lot / code info
- Lot: 12DE1806 Exp. 01/31/2021
Why it was recalled
CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
Recalling firm
- Firm
- Direct Rx
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 94 Worldwide Dr, N/A, Dawsonville, Georgia 30534-6828
Distribution
- Quantity
- 33 bottles
- Distribution pattern
- FL
Timeline
- Recall initiated
- 2019-03-12
- FDA classified
- 2020-10-12
- Posted by FDA
- 2020-10-07
- Terminated
- 2021-09-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0032-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.