Edge Pharma Recalls Betadine Ophthalmic Syringes Due to Sterility Concerns
Edge Pharma is recalling 5,850 syringes of Betadine ophthalmic solution because a defective container may compromise sterility. The product is distributed nationwide.
What this means for you
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: The recall is classified as FDA Class II, and the hazard involves a potential lack of sterility assurance due to a container defect. No illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Edge Pharma, LLC is recalling 5,850 syringes of Betadine (Povidone-Iodine) 5% sterile ophthalmic solution. The recall involves single-use syringes containing 0.5mL of preservative-free solution intended for topical ophthalmic use. The affected product is identified by Lot 02-2021-16@4 with a beyond-use date of 5/31/2021.
The recall was initiated due to a defective container where syringe content may migrate past the seal of the plunger. This defect may cause a lack of assurance of sterility. The product was distributed nationwide in the US.
Consumers should stop using the recalled syringes and contact Edge Pharma, LLC at 1-802-992-1178 for further instructions. The product is prescription-only and should not be injected.
The recalled product
- Product
- Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC SOLUTION, PRESERVATIVE FREE, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Ophthalmic Solution
- Affected units
- 5,850
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)
- Lot 02-2021-16@4 BUD 5/31/2021
Distribution
Distributed nationwide across the United States.
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