FDAFDA · Food and drugs·Recall number D-809-2013
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.
Published July 31, 2013 · Recall initiated: January 3, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Brand
- MITOSOL
- Manufacturer
- Mobius Therapeutics LLC
- Distributor
- Nationwide and Military and Government Consignees
- Lot
- Lot #: M086920 and M098260, Exp. 08/2013
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States