Betadine Sterile Ophthalmic Solution Recalled for Sterility Assurance
Edge Pharma is recalling Betadine sterile ophthalmic solution syringes due to lack of assurance of sterility. The affected product is a preservative-free, single-use ophthalmic solution 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 3/5 (High).
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 an FDA Class II recall of a sterile injectable ophthalmic product with a lack of sterility assurance, which presents a high risk of serious harm (ocular infection) to patients, though no illnesses or injuries have been reported in the source text. The hazard is direct and significant for a sterile product category.
Plain-English summary
Edge Pharma, LLC is recalling Betadine (povidone-iodine) sterile ophthalmic solution, preservative-free, 5% in 0.5mL single-use syringes (NDC 05446-1680-01) due to lack of assurance of sterility. Approximately 1,773 syringes with code 10-2021-25@5 12/09/2021 have been distributed nationwide.
A sterile ophthalmic solution that cannot be assured to be sterile poses a risk of infection if administered to the eye. Consumers and healthcare providers who have this product should discontinue use and consult their healthcare provider.
The recalled product
- Product
- Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446, NDC 05446-1680-01
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Ophthalmic Solution
- Affected units
- 1,773
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)
- 10-2021-25@5 12/09/2021
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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