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
Reported: April 28, 2021 Initiated: April 12, 2021 #D-0335-2021
Product Description
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
Reason for Recall
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
Details
- Recalling Firm
- Edge Pharma, LLC
- Units Affected
- 5850 syringes
- Distribution
- Nationwide in the US
- Location
- Colchester, VT
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Edge Pharma, LLC. Units affected: 5850 syringes.
Why was this product recalled? ▼
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 28, 2021. Severity: Moderate. Recall number: D-0335-2021.
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