FDA recall D-0335-2021

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

Reason for recall

Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility

Distribution

Nationwide in the US

Key facts

Status

Terminated

Initiation date

2021-04-12

Report date

2021-04-28

Termination date

2022-02-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Colchester, VT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0335-2021