Drug recall
Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap…
FDA recall event 85880 · Class II · Preferred Pharmaceuticals, Inc.
Key facts
| Event ID | 85880 |
|---|---|
| Recall numbers | D-1364-2020 |
| Recalling firm | Preferred Pharmaceuticals, Inc. |
| Product type | Drugs |
| Products | Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap, Labs Inc., Farmingdale, NY, Preferred Pharmaceuticals, Anaheim, CA NDC: 68788-6932-01 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. |
| Initiation date | Jun 17, 2020 |
| Report date | Jul 8, 2020 |
| Termination date | Mar 21, 2024 |
| City | Anaheim |
| State | CA |
| Country | United States |
| FEI number | 3004582966 |
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: