FDA Recalls Mitomycin Ophthalmic Solution for Sterility Assurance Failure
Pharmacy Innovations is recalling Mitomycin ophthalmic solutions nationwide due to a lack of sterility assurance. An FDA inspection found insanitary conditions at the manufacturing facility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II recall for a sterile ophthalmic product lacking sterility assurance due to insanitary facility conditions. Per the rubric, a risk-of-harm product without reported illness qualifies as High severity (score 3).
Plain-English summary
Pharmacy Innovations is recalling Mitomycin 0.4mg/ml ophthalmic solutions (1ml Droptainer, 1ml vial, and 4ml vial) distributed nationwide. The recall is due to a lack of assurance of sterility. During an FDA inspection, insanitary conditions were discovered at the manufacturing facility in Erie, Pennsylvania.
The affected product codes are t20221108@20, t20221026@25, and t20221116@36. Mitomycin is a prescription ophthalmic solution used in eye care.
Patients and healthcare providers who have received this product should cease use and contact Pharmacy Innovations or their healthcare provider for guidance on proper disposal and next steps. This is a Class II recall.
The recalled product
- Product
- MITOMYCIN 0.4MG/ML (1ML DROPTAINER) OPH SOLUTION; MITOMYCIN 0.4MG/ML (1ML VIAL) OPH SOLUTION; MITOMYCIN 0.4MG/ML (4ML VIAL) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Ophthalmic Solution
- Hazard
- sterility-assurance
- contamination
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 (1)
- t20221108@20 t20221026@25 t20221116@36
Distribution
Distributed nationwide across the United States.
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