Reported Nov 11, 2020 · Terminated
Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90
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?
Metformin HCL E/R 500 mg90 Tabs
- Packaged and Distributed ByDirect Rx Dawsonville, GA 30534 NDC 72189-064-90
- Lot codes and dates
- Lot
04DE190211DE1908 Exp. 06/30/2021
- Lot
- Amount recalled
- 88 bottles
Where it was sold
Why it was recalled
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
This product could cause temporary or reversible health problems — stop using it.
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