The Recall Desk
SevereFDA (Drugs)·D-809-2013·Announced 2013-07-31

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Hazard
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.

Related recalls

Same hazard · yeast contamination

See all →