Drug recall
Metformin HCl Tablets USP, 1000 mg, packaged in 500 count bottles, Rx only, Manufactured in India by: Matrix…
FDA recall event 57945 · Class III · Mylan Pharmaceuticals Inc.
Key facts
| Event ID | 57945 |
|---|---|
| Recall numbers | D-431-2011, D-432-2011 |
| Recalling firm | Mylan Pharmaceuticals Inc. |
| Product type | Drugs |
| Products | Metformin HCl Tablets USP, 1000 mg, packaged in 500 count bottles, Rx only, Manufactured in India by: Matrix Laboratories Limited (NDC 0378-7187-05), Manufactured for: Mylan Pharmaceuticals Inc…, Metformin HCl Tablets USP, 500 mg, packaged in 500 count bottles, Rx only, Manufactured in India by: Matrix Laboratories Limited NDC 0378-7185-05 Manufactured for: Mylan Pharmaceuticals Inc… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Pharmaceutical available by prescription only may contain oversized tablets., Superpotent (Single Ingredient Drug): Pharmaceutical available by prescription only may contain oversized tablets. |
| Initiation date | Feb 8, 2011 |
| Termination date | Nov 2, 2011 |
| City | Morgantown |
| State | WV |
| Country | United States |
| FEI number | 1110315 |
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