Mitomycin-C Ophthalmic Solution Recall Due to Sterility Assurance
Edge Pharma is recalling Mitomycin-C sterile ophthalmic solution syringes because the manufacturer lacks assurance of sterility. The recall affects 154 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a sterility assurance issue for a pharmaceutical product. The source text does not report any illnesses, injuries, or confirmed contamination—only a lack of assurance of sterility. Per the severity rubric, sterility concerns without reported adverse outcomes and without FDA Class I classification warrant a Moderate rating.
Plain-English summary
Edge Pharma, LLC is recalling Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free (0.16 mg/0.8 mL concentration, 0.8 mL per syringe, single-use syringe) with NDC 05446-1011-01 due to lack of assurance of sterility.
The recall was initiated because the manufacturer cannot confirm that the affected syringes meet required sterility standards. A total of 154 syringes were distributed nationwide.
Patients currently using this product should contact their healthcare provider to discuss next steps. Healthcare providers should discontinue use of the recalled product and contact Edge Pharma, LLC at 856 Hercules Drive, Colchester, VT 05446 for additional information.
The recalled product
- Product
- Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.2 mg/mL), 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1011-01
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Ophthalmic Solution
- Affected units
- 154
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@9 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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