FDA-Drug2013-07-31Class I

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.

Mobius Therapeutics LLC
Hazard

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

Sold states
Nationwide and Military and Government Consignees
Affected count
83 boxes
Manufactured in
4041 Forest Park Ave, N/A, Saint Louis, MO, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-809-2013

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