Drug 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.
D-809-2013
Product summary
- Event
- Event 64018
- Status
- Terminated
- Classification
- Class I
- Quantity
- 83 boxes
- Official record key
drug-enforcement:D-809-2013
Official wording
Reason: Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.
Code information: Lot #: M086920 and M098260, Exp. 08/2013
Distribution pattern: Nationwide and Military and Government Consignees
Derived failure modes
-
Microbial contamination
found to be contaminated with yeast