Mitomycin solution recalled

January 25, 2013

Mobius Therapeutics LLC is conducting a recall of two lots of mitomycin for solution 0.2 mg/vial (Mitosol Kit for Ophthalmic Use) because the affected lots may be non-sterile.

 

St. Louis, MO-Mobius Therapeutics LLC is conducting a recall of two lots of mitomycin for solution 0.2 mg/vial (Mitosol Kit for Ophthalmic Use). The company is taking this voluntary action because it cannot exclude the possibility that the affected lots may be non-sterile.

These two lots may contain a strain of yeast on one or more parts in the kit and should be considered non-sterile and unsafe for use. The affected lots are Mitosol Kit for Ophthalmic Use, NDC# 49771-002-01, Expiration date 08/2013, Lot numbers M098260 and M086920.

Mobius has initiated an investigation to determine the root cause and corrective and preventative actions.

Questions may be directed to Mobius by dialing 1-877/EYE-MITO (1/877-393-6486) and pressing option “2” Monday to Friday, 8:00 a.m. to 5:00 p.m. CST. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

 

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