D-809-2013 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 31, 2013
- Initiation Date
- January 3, 2013
- Termination Date
- July 29, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 83 boxes
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.
Reason for Recall
Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.
Distribution Pattern
Nationwide and Military and Government Consignees
Code Information
Lot #: M086920 and M098260, Exp. 08/2013