Mitosol recall: Sterility Concern
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…
Why was Mitosol recalled?
Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: M086920 and M098260, Exp. 08/2013
- 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…
- Recalling firm
- Mobius Therapeutics LLC
- Quantity
- 83 boxes
- Distribution
- Nationwide and Military and Government Consignees
- Recall date
- July 31, 2013
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)