Edge Pharma, LLC recalls Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT)
Recalled April 28, 2021 · FDA recall D-0335-2021 · Edge Pharma
Hazard
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility · FDA Class II
Units
5850 syringes
Sold at
Nationwide in the US
Description
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
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(s)
Edge Pharma, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →