Drug recall
metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets…
FDA recall event 85828 · Class II · PD-Rx Pharmaceuticals, Inc.
Key facts
| Event ID | 85828 |
|---|---|
| Recall numbers | D-1333-2020 |
| Recalling firm | PD-Rx Pharmaceuticals, Inc. |
| Product type | Drugs |
| Products | 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)… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level |
| Initiation date | Jun 5, 2020 |
| Report date | Jul 1, 2020 |
| Termination date | Nov 8, 2021 |
| City | Oklahoma City |
| State | OK |
| Country | United States |
| FEI number | 1641825 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: