FDA-Drug2021-04-28Class II
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
Edge Pharma, LLC
Hazard
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
Sold states
Nationwide in the US
Affected count
5850 syringes
Manufactured in
856 Hercules Dr, N/A, Colchester, VT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0335-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief