January 2013 FDA Recall Mitosol by Mobius Therapeutics Llc
D-809-2013 - Non-Sterility
This Class I drug recall was voluntarily initiated by Mobius Therapeutics Llc on January 3, 2013 for the product Mitosol. The FDA reported the reason for recall as non-sterility. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-809-2013
Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.
01-03-2013
07-31-2013
83 boxes
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Mobius Therapeutics LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Military and Government Consignees
07-29-2013
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# : M086920 and M098260, Exp. 08/2013
