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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Product Detail

Product Description 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.
Recall Number D-809-2013
Classification Class I
Code Info Lot #: M086920 and M098260, Exp. 08/2013
Product Distributed Qty 83 boxes
Reason For Recall Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.

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 Telephone
Distribution Pattern Nationwide and Military and Government Consignees