Reported Oct 14, 2020 · Terminated
Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC…
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 Potassium 100 mg30 Tabs bottlesRx only
- Packaged and Distributed ByDirect Rx Dawsonville, GA 30534 NDC 61919-952-30
- Lot codes and dates
- Lot27AU1801 Exp. 02/28/2021
- Amount recalled
- 33 bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
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 per manufacturer
This product could cause temporary or reversible health problems — stop using it.
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