Recalls / Class I
Class ID-809-2013
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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.
- Brand name
- Mitosol
- Generic name
- Mitomycin
- NDC
- 49771-002
- FDA application
- NDA022572
- Affected lot / code info
- Lot #: M086920 and M098260, Exp. 08/2013
Why it was recalled
Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.
Recalling firm
- Firm
- Mobius Therapeutics LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 4041 Forest Park Ave, N/A, Saint Louis, Missouri 63108-3213
Distribution
- Quantity
- 83 boxes
- Distribution pattern
- Nationwide and Military and Government Consignees
Timeline
- Recall initiated
- 2013-01-03
- FDA classified
- 2013-07-19
- Posted by FDA
- 2013-07-31
- Terminated
- 2013-07-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-809-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.