Home / Recalls / Direct Rx / D-0058-2021

D-0058-2021 Class II Terminated

Recalled by Direct Rx — Dawsonville, GA

Recall Details

Product Type
Drugs
Report Date
November 11, 2020
Initiation Date
October 12, 2020
Termination Date
September 22, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
88 bottles

Product Description

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

Reason for Recall

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

Distribution Pattern

FL

Code Information

Lot: 04DE1902, 11DE1908 Exp. 06/30/2021

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