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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Event Detail

Event ID 64018
Product Type Drugs
Status Ongoing
Recalling Firm Mobius Therapeutics LLC
City Saint Louis
State MO
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-03
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide and Military and Government Consignees

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use (NDC 49771-002-01), 3 kits per box (NDC 49771-002-03), Rx only, Manufactured for: Mobius Therapeutics, LLC, 4041 Forest Park Avenue, St. Louis, MO 63108 USA. Lot #: M086920 and M098260, Exp. 08/2013 Class I Non-Sterility: one or more components of the kit have been found to be contaminated with yeast. 83 boxes D-809-2013