Class II
Terminated
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
- Company
- Direct Rx
- Recall Initiated
- March 12, 2019
- Posted
- October 7, 2020
- Recall Number
- D-0032-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 33 bottles
- Firm Location
- Dawsonville, GA, United States
Reason for Recall
CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
Distribution
FL
Lot / Code Info
Lot: 12DE1806 Exp. 01/31/2021
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