• COVID-19
  • Biosimilars
  • Cataract Therapeutics
  • DME
  • Gene Therapy
  • Workplace
  • Ptosis
  • Optic Relief
  • Imaging
  • Geographic Atrophy
  • AMD
  • Presbyopia
  • Ocular Surface Disease
  • Practice Management
  • Pediatrics
  • Surgery
  • Therapeutics
  • Optometry
  • Retina
  • Cataract
  • Pharmacy
  • IOL
  • Dry Eye
  • Understanding Antibiotic Resistance
  • Refractive
  • Cornea
  • Glaucoma
  • OCT
  • Ocular Allergy
  • Clinical Diagnosis
  • Technology

Mitomycin solution recalled

Article

Mobius Therapeutics LLC is conducting a recall of two lots of mitomycin for solution 0.2 mg/vial (Mitosol Kit for Ophthalmic Use) because the affected lots may be non-sterile.

 

St. Louis, MO-Mobius Therapeutics LLC is conducting a recall of two lots of mitomycin for solution 0.2 mg/vial (Mitosol Kit for Ophthalmic Use). The company is taking this voluntary action because it cannot exclude the possibility that the affected lots may be non-sterile.

These two lots may contain a strain of yeast on one or more parts in the kit and should be considered non-sterile and unsafe for use. The affected lots are Mitosol Kit for Ophthalmic Use, NDC# 49771-002-01, Expiration date 08/2013, Lot numbers M098260 and M086920.

Mobius has initiated an investigation to determine the root cause and corrective and preventative actions.

Questions may be directed to Mobius by dialing 1-877/EYE-MITO (1/877-393-6486) and pressing option “2” Monday to Friday, 8:00 a.m. to 5:00 p.m. CST. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

 

For more articles in this issue of Ophthalmology Times eReport, click here.

Related Videos
Neda Nikpoor, MD, talks about the Light Adjustable Lens at ASCRS 2024
Elizabeth Yeu, MD, highlights from a corneal case report for a patient undergoing the triple procedure
William F. Wiley, MD, shares some key takeaways from his ASCRS presentation on binocularity and aperture optics.
© 2024 MJH Life Sciences

All rights reserved.