Reported Oct 7, 2020 · Terminated
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent…
Direct Rx
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Direct Rx · 94 Worldwide Dr · Dawsonville, GA · 30534-6828
Is this the product you have?
- Losartan Pot/HCTZ 50/12.5
- mg 90 Tabs Packaged and Distributed ByDirect Rx Dawsonville
- GA 30534 Mfg ForTorrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90
- Lot codes and dates
- Lot12DE1806 Exp. 01/31/2021
- Amount recalled
- 33 bottles
Where it was sold
Why it was recalled
CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
This product could cause temporary or reversible health problems — stop using it.
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