Drug recall D-809-2013

Class I Terminated reported Jul 31, 2013

Product

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.

Reason for recall

Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.

Lots and codes

Lot #: M086920 and M098260, Exp. 08/2013

Recall details

Recalling firm
Mobius Therapeutics LLC, Saint Louis, MO
Quantity
83 boxes
Distribution
Nationwide and Military and Government Consignees
Type
Voluntary: Firm initiated
Recall initiated
January 3, 2013
Terminated
July 29, 2013

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