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

Firm: Mobius Therapeutics LLC

Classification: Class I

Status: Terminated

Report Date: 20130731

Initiation Date: 20130103

Termination Date: 20130729

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

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.