Product Detail

Product Description 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

Classification Class I

Code Info Lot #: M086920 and M098260, Exp. 08/2013

Product Distributed Qty 83 boxes

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

Event Detail

Event Id 64018

Product Type Drugs

Status Ongoing

Recalling Firm

Mobius Therapeutics LLC
City Saint Louis

State MO
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-01-03

Initial Firm Notification of Consignee or Public Telephone

Distribution Pattern Nationwide and Military and Government Consignees