Drug recall
Alprazolam Extended-release Tablets, USP, 2mg, 60 count bottle, Rx Only, Mylan Pharmaceuticals Inc…
FDA recall event 61541 · Class II · Mylan Pharmaceuticals Inc.
Key facts
| Event ID | 61541 |
|---|---|
| Recall numbers | D-1361-2012 |
| Recalling firm | Mylan Pharmaceuticals Inc. |
| Product type | Drugs |
| Products | Alprazolam Extended-release Tablets, USP, 2mg, 60 count bottle, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-5023-91 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed USP Dissolution Test Requirements: Routine stability testing for Alprazolam XR tablets yielded out of specification dissolution results. |
| Initiation date | Apr 3, 2012 |
| Termination date | Dec 3, 2012 |
| 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