Reported Apr 28, 2021 · Terminated
Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT)…
Edge Pharma, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edge Pharma, LLC · 856 Hercules Dr · Colchester, VT · 05446-8014
Is this the product you have?
- 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
- Lot codes and dates
- Lot 02-2021-16@4 BUD 5/31/2021
- Amount recalled
- 5850 syringes
Where it was sold
- Nationwide
Why it was recalled
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
This product could cause temporary or reversible health problems — stop using it.
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