Class I · High risk Ongoing
Optiray Imaging Bulk Package-350
Reason Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Betadine Solution Swabstick Povidone-Iodine Solution USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic reaction between the free iodine and the aluminum.
What was recalled
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01
- Recalling firm
- Purdue Pharma, LP
- NDC code
- 67618-153-01
- Origin
- CT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0070-2018
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.
Other Iodine recalls
See all
Class II · Moderate risk Ongoing
BD PurPrep
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
Class II · Moderate risk Ongoing
Povi-One
Reason sub potency
Class II · Moderate risk Ongoing
BD PurPrep
Reason Lack of assurance of Sterility: potential product contamination
Class II · Moderate risk Ongoing
BD PurPrep
Reason Lack of assurance of Sterility: potential product contamination
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