Mitomycin Ophthalmic Solution Recalled Nationwide Over Sterility Assurance
Pharmacy Innovations is recalling Mitomycin 0.2mg/ml ophthalmic solution nationwide due to lack of sterility assurance following FDA facility inspection findings.
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: FDA Class II recall involving a high-risk pharmaceutical product requiring sterility. No reported illnesses or confirmed contamination, but the product poses direct risk of harm (eye infections) if non-sterile, meeting the criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Pharmacy Innovations is recalling Mitomycin 0.2mg/ml ophthalmic solution nationwide. The product is available in 1ml Droptainer and 1ml vial forms. The recall was initiated due to lack of assurance of sterility.
An FDA inspection of the manufacturer's facility in Erie, Pennsylvania revealed insanitary conditions that could compromise the sterility of the product. Mitomycin is a prescription medication used in ophthalmic procedures, and non-sterile eye drops could potentially cause eye infections.
The product was distributed nationwide. Patients and healthcare providers who have received this medication should contact their pharmacist or healthcare provider for guidance. The recalled product codes are t20221004@8 and t20221011@36.
The recalled product
- Product
- MITOMYCIN 0.2MG/ML (1ML DROPTAINER) OPH SOLUTION; MITOMYCIN 0.2MG/ML (1ML VIAL) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Ophthalmic Solution
- Hazard
- lack-of-sterility
- contamination-risk
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)
- t20221004@8 t20221011@36
Distribution
Distributed nationwide across the United States.
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