Enforcement Report - Week of January 9, 2013
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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. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01 | Lots: 3027684 Exp. 5/13, 3027688 Exp. 6/13 & 2002157 Exp. 9/12 | Class II | Failed USP Content Uniformity Requirements: OOS result reported on retained samples. | 15181 bottles. | D-066-2013 |
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