FDA Drug recall D-0059-2021
metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30
- FDA Drug
- Class II
- terminated
- Published 2020-11-11
On 2020-11-11 the FDA classified a Class II recall of metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30 by Pd Rx Pharmaceuticals, 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-0059-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-06 |
| Published | 2020-11-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pd Rx Pharmaceuticals |
| Distribution | AK, AZ, CA, CO, FL, GA, ID, IL, IN, KY, MN, NC, NY, OK, OR, WI |
Product
metformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: 72789-009-60; c) 90 tablets NDC: 72789-009-90; d) 180 tablets NDC: 72789-009-93 bottles, Rx only, Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127
Reason
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Identifiers
| ndc | 72789-009-30 |
|---|---|
| ndc | 72789-009-60 |
| ndc | 72789-009-90 |
| ndc | 72789-009-93 |
| code_info | Lots: a) B20D23, B20D67 Exp. 07/31/21, C20D55 Exp. 12/31/21; b) A20D92, A20F59, B20C16 Exp. 07/31/21, C20D63, D20A4…Lots: a) B20D23, B20D67 Exp. 07/31/21, C20D55 Exp. 12/31/21; b) A20D92, A20F59, B20C16 Exp. 07/31/21, C20D63, D20A45, D20C80 Exp. 12/31/21, G20D46, I20C57 Exp. 04/30/22; c) A20D90, A20E77, A20F69, B20F43 Exp. 07/31/21, C20B14, D20A41 Exp. 12/31/21, I20D94, I20E56, J20A28 Exp. 04/30/22; d) B20B96 Exp. 07/31/21, C20C28, C20E58, D20B17 Exp. 12/31/21, G20D91 Exp. 04/30/22 |
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-0059-2021%22
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