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U.S. Department of Health and Human Services

Enforcement Report - Week of January 9, 2013

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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.