Mobius Recalls Mitosol Ophthalmic Kits Due to Yeast Contamination
Mobius Therapeutics is recalling 83 boxes of Mitosol ophthalmic kits because components were found to be contaminated with yeast.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which meets the rubric criterion for a score of 4 (Severe) as agency Class I classifications must not be scored below 4.
Plain-English summary
Mobius Therapeutics LLC is recalling 83 boxes of Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use. The recall involves specific lots (M086920 and M098260) with an expiration date of 08/2013. The product is a prescription-only medication manufactured for Mobius Therapeutics, LLC.
The recall was initiated because one or more components of the kit have been found to be contaminated with yeast, indicating a non-sterility issue. The affected product was distributed nationwide to military and government consignees.
Consumers and healthcare providers should stop using the affected Mitosol kits and contact their healthcare provider or Mobius Therapeutics for further instructions on disposal or replacement.
The recalled product
- Product
- MITOSOL (MITOMYCIN)
- Brand
- MITOSOL
- Manufacturer
- Mobius Therapeutics LLC
- Category
- Drug — Ophthalmic
- Affected units
- 83
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: M086920 and M098260
- Exp. 08/2013
Distribution
Distributed nationwide across the United States.
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