Drug recall
Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505…
FDA recall event 62454 · Class II · Mylan LLC.
Key facts
| Event ID | 62454 |
|---|---|
| Recall numbers | D-066-2013 |
| Recalling firm | Mylan LLC. |
| Product type | Drugs |
| Products | Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed USP Content Uniformity Requirements: OOS result reported on retained samples. |
| Initiation date | Jun 29, 2012 |
| Report date | Dec 5, 2012 |
| Termination date | Apr 13, 2017 |
| City | Caguas |
| State | PR |
| Country | United States |
| FEI number | 2650176 |
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 · Source date: