Drug recall
Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx…
FDA recall event 87833 · Class II · Preferred Pharmaceuticals, Inc.
Key facts
| Event ID | 87833 |
|---|---|
| Recall numbers | D-0385-2021 |
| Recalling firm | Preferred Pharmaceuticals, Inc. |
| Product type | Drugs |
| Products | Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Labs Inc.; Farmingdale NY, NDC #: 68788-6932-1 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day. |
| Initiation date | Apr 28, 2021 |
| Report date | May 26, 2021 |
| 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: