FDA Drug Class II — Moderate

Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90

Hazard

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

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Products

Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90
Brand
Direct Rx
UPC
Lot: 04DE1902, 11DE1908 Exp. 06/30/2021

Units Affected

88 bottles

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