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U.S. Department of Health and Human Services

Enforcement Report - Week of May 29, 2013

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Event Detail

Event ID 65115
Product Type Drugs
Status Ongoing
Recalling Firm Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
City Rockford
State IL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-15
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed by: UDL Laboratories, Inc., Rockford, IL 61103, NDC 51079-020-03. Lot No: 3037382, Exp 09/13 Class III Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing. 1,621 boxes D-452-2013
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