Status
Terminated
Drug Enforcement D-809-2013
Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.
Classification
Class I
Report Date
July 31, 2013
Termination Date
July 29, 2013
Product Information
- Product description
- 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.
- Product quantity
- 83 boxes
- Reason for recall
- Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Nationwide and Military and Government Consignees
Location & Firm
- Recalling firm
- Mobius Therapeutics LLC
- Address
-
4041 Forest Park Ave, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-809-2013
- Event ID
- 64018
- Recall initiation date
- January 3, 2013
- Center classification date
- July 19, 2013
- Code info
- Lot #: M086920 and M098260, Exp. 08/2013
- More code info
- —