FDA Recall D-809-2013
Mobius Therapeutics LLC · Saint Louis, MO
Class I — life-threatening Terminated 207 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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.
Reason for recall
Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.
Recall record
- Recall number
D-809-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- Nationwide and Military and Government Consignees
- Recall initiated
- 2013-01-03
- Classified by FDA Center
- 2013-07-19
- FDA published
- 2013-07-31
- Terminated
- 2013-07-29
- Recalling firm
- Mobius Therapeutics LLC
- Firm location
- Saint Louis, MO
Drug identification
- Brand name(s)
- MITOSOL
- Generic name(s)
- MITOMYCIN
- Manufacturer(s)
- Mobius Therapeutics LLC
- NDC(s)
49771-002