Mitosol Kit
FDA Recall NDC 49771-002
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Mitosol (NDC 49771-002). A significant event, classified as Class I, was initiated on Jan 03, 2013 by Mobius Therapeutics Llc. The reported reason for this action was: "Non-Sterility: one or more components of the kit have been found to be contaminated with yeast."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.
Jan 03, 2013
Jul 31, 2013
83 boxes
Recall Profile & Regulatory Data
Event ID
64018
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Mobius Therapeutics LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Military and Government Consignees
Termination Date
Jul 29, 2013
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.
Batch or Lot Expiration Information
Lot# : M086920 and M098260, Exp. 08/2013
Affected Packages Involved in this Recall
49771-002-01Product
49771-002-03Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
