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U.S. Department of Health and Human Services

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