Why it was recalled
Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.
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.
Lot numbers, UPCs & expiration codes
Lot #: M086920 and M098260, Exp. 08/2013
Where it was sold
Nationwide and Military and Government Consignees
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-809-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 3, 2013
- FDA report date
- Jul 31, 2013
- Quantity
- 83 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mobius Therapeutics LLC
Original FDA data
Every field from FDA enforcement report D-809-2013, exactly as published.
Show all FDA fields
- City
- Saint Louis
- State
- MO
- Status
- Terminated
- Country
- United States
- Event ID
- 64018
- Address
- 4041 Forest Park Ave
- Code information
- Lot #: M086920 and M098260, Exp. 08/2013
- Postal code
- 63108-3213
- Report date
- Jul 31, 2013
- Product type
- Drugs
- Recall number
- D-809-2013
- Classification
- Class I
- Recalling firm
- Mobius Therapeutics LLC
- Product quantity
- 83 boxes
- Termination date
- Jul 29, 2013
- Reason for recall
- Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide and Military and Government Consignees
- Recall initiation date
- Jan 3, 2013
- Initial firm notification
- Telephone
- Center classification date
- Jul 19, 2013