FDA recall D-0058-2021

Direct Rx · Class II · drug

Product

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

FL

Key facts

Status: Terminated
Initiation date: 2020-10-12
Report date: 2020-11-11
Termination date: 2021-09-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Dawsonville, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0058-2021