Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Reason Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…
Reason sub potency
Reason Lack of assurance of Sterility: potential product contamination
Reason Lack of assurance of Sterility: potential product contamination
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