Optiray Imaging Bulk Package-350
Reason Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
SubPotent: Out of Specification
PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S41125 NDC 10819-3885-2, UPC (01)00310819000185
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 distributed to customers outside of the intended distribution channel
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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