Mitomycin-C Sterile Ophthalmic Solution Lacks Sterility Assurance
Edge Pharma is recalling Mitomycin-C Sterile Ophthalmic Solution because the manufacturer cannot assure that the product is sterile. The recall affects 163 syringes distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 FDA classified this as a Class II recall. A sterility defect in a sterile ophthalmic solution poses a significant risk of serious injury, including infection or vision loss, if non-sterile product is administered directly to the eye. Although no illnesses are reported in the source text, the hazard is inherent to the defect itself, meeting the threshold for Severe.
Plain-English summary
Edge Pharma, LLC is recalling Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) in single-use syringes for topical ophthalmic use. The product has NDC 05446-1009-01 and the affected lot code is 11-2021-08@8 with an expiration date of 12/18/2021.
The recall has been initiated due to lack of assurance of sterility. The manufacturer cannot verify that the product meets sterility standards required for ophthalmic use.
A total of 163 syringes have been distributed nationwide. Patients who have received this product should consult their healthcare provider. Healthcare facilities should quarantine any affected inventory and not dispense the recalled product.
The recalled product
- Product
- Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1009-01
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Ophthalmic
- Affected units
- 163
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)
- 11-2021-08@8 12/18/2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 recalled by Edge Pharma, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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