FDA Drug recall D-0058-2021
Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90
- FDA Drug
- Class II
- terminated
- Published 2020-11-11
On 2020-11-11 the FDA classified a Class II recall of Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90 by Direct Rx, citing CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0058-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-12 |
| Published | 2020-11-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Direct Rx |
| Distribution | FL |
Product
Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90
Reason
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Identifiers
| ndc | 72189-150-90 |
|---|---|
| ndc | 72189-150-30 |
| ndc | 72189-064-90 |
| ndc | 72189-064-30 |
| code_info | Lot: 04DE1902, 11DE1908 Exp. 06/30/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0058-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.