Drug recall
Glyburide (micronized) and Metformin HCl tablets, 1.25 mg/250 mg, 100-count bottle NDC 0781-5170-01; 500-count…
FDA recall event 54524 · Class II · Corepharma Llc
Key facts
| Event ID | 54524 |
|---|---|
| Recall numbers | D-527-2010, D-528-2010, D-529-2010 |
| Recalling firm | Corepharma Llc |
| Product type | Drugs |
| Products | Glyburide (micronized) and Metformin HCl tablets, 1.25 mg/250 mg, 100-count bottle NDC 0781-5170-01; 500-count bottle NDC 0781-5170-05; Rx only, Manufactured by Corepharma LLC, Middlesex, NJ 08846…, Glyburide(micronized) and Metformin HCL Tablets; 2.5 mg/500 mg,100 count bottle NDC 0781-5171-01, 2.5 mg/500 mg,500 count bottle NDC 0781-5171-05, Rx only Manufactured by Corepharma LLC, Middlesex, NJ…, Glyburide(micronized) and Metformin HCL Tablets; 5 mg/500 mg,100 count bottle NDC 0781-5172-01, 5 mg/500 mg,500 count bottle NDC 0781-5172-05, Rx only Manufactured by Corepharma LLC, Middlesex, NJ… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Tablets have the potential to contain metal particulates. |
| Initiation date | Jan 22, 2010 |
| Termination date | Jun 13, 2012 |
| City | Middlesex |
| State | NJ |
| Country | United States |
| FEI number | 3002535019 |
At a glance
- 1–9 Products in this recall
- 10–99 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