FDA-Drug2020-11-11Class II
Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90
Direct Rx
Hazard
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Sold states
FL
Affected count
88 bottles
Manufactured in
94 Worldwide Dr, N/A, Dawsonville, GA, United States
Products
Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0058-2021Don't want to check this manually?
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