MVASI Sterile Ophthalmic Solution Lacks Assured Sterility
Edge Pharma is recalling MVASI (bevacizumab-awwb) intraocular injection syringes nationwide due to lack of assurance of sterility. The recall affects 199 syringes with code 11-2021-01@2 dated 12/15/2021.
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: This is an FDA Class II recall involving a sterile injectable pharmaceutical product. Lack of sterility assurance on a solution intended for direct intraocular injection poses a significant risk of serious infection, meeting the Severe threshold even though no reported illnesses are stated in the source.
Plain-English summary
Edge Pharma, LLC is recalling MVASI (bevacizumab-awwb), a sterile ophthalmic solution for injection supplied in single-use syringes. The product is a 3.25 mg/0.13 mL solution (25 mg/mL per syringe) intended for intraocular injection, with a dose of 1.25 mg/0.05 mL. The recall involves 199 syringes with lot code 11-2021-01@2 dated 12/15/2021 and NDC 05446-1661-13.
The recall is due to lack of assurance of sterility. Non-sterile injectable solutions can pose a serious risk of infection when administered directly into the eye.
Patients who received this product should contact their healthcare provider immediately for evaluation. Healthcare facilities should stop use of affected syringes and contact Edge Pharma, LLC for instructions on product return and replacement.
The recalled product
- Product
- MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.13mL (25 mg/mL) 0.13 mL per syringe, Dose: 1.25mg/0.05mL, Single Use Syringe For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1661-13
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Intraocular Injection
- Affected units
- 199
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)
- 11-2021-01@2 12/15/2021
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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