FDA Drug recall D-1333-2020
metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30)
- FDA Drug
- Class II
- terminated
- Published 2020-07-01
On 2020-07-01 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: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1333-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-05 |
| Published | 2020-07-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pd Rx Pharmaceuticals |
| Distribution | n/a |
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); e) 100 tablets (NDC 49483-0623-01) bottles, Rx only PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127
Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Identifiers
| ndc | 72789-009-30 |
|---|---|
| ndc | 72789-009-60 |
| ndc | 72789-009-90 |
| ndc | 72789-009-93 |
| ndc | 49483-0623-01 |
| code_info | Lots: a) A20B02, I19D03, J19A98, K19E32, L19C86 Exp. 12/31/2020; b) I19D55, I19F50, K19A18, K19D87, L19B34, L19D23…Lots: a) A20B02, I19D03, J19A98, K19E32, L19C86 Exp. 12/31/2020; b) I19D55, I19F50, K19A18, K19D87, L19B34, L19D23, L19E74 Exp. 12/31/2020; c) I19E91, I19F33, J19B88, J19E70, K19D26, L19A65 Exp. 12/31/2020; d) I19C21 Exp. 08/21/2020, I19C57, J19C21, J19C67, K19B53, L19C77, L19E44 Exp. 12/31/2020; e) XP9004 Exp. 12/31/2020 |
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-1333-2020%22
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