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.

FDA recall notice · announced July 31, 2013 · Mobius Therapeutics

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Notes

Distribution: Nationwide and Military and Government Consignees
Lot/code information: Lot #: M086920 and M098260, Exp. 08/2013
Quantity: 83 boxes
Status: Terminated
Products in this recall event:
- 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 Avenu (D-809-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.