Enforcement Report - Week of January 9, 2013
-
Back to Previous Page
Product Detail
| Product Description | Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01 |
|---|---|
| Recall Number | D-066-2013 |
| Classification | Class II |
| Code Info | Lots: 3027684 Exp. 5/13, 3027688 Exp. 6/13 & 2002157 Exp. 9/12 |
| Product Distributed Qty | 15181 bottles. |
| Reason For Recall | Failed USP Content Uniformity Requirements: OOS result reported on retained samples. |
Event Detail
| Event Id | 62454 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Mylan LLC. |
| City | Caguas |
| State | PR | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-06-29 |
| Initial Firm Notification of Consignee or Public | |
| Distribution Pattern | Natiowide. |
-
