FDA recall D-809-2013

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.

Distribution

Nationwide and Military and Government Consignees

Key facts

Status

Terminated

Initiation date

2013-01-03

Report date

2013-07-31

Termination date

2013-07-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Louis, MO, United States

Primary source

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