Class I — High risk. Reasonable probability of serious harm or death.
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Made in USA, NDC 0019-1333-65.
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 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
Reason Subpotent drug
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