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.
Lugol's
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Products not manufactured under current good manufacturing practices.
What was recalled
Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single Use Vials, Rx Only, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6064-0, Ref 6064.
- Recalling firm
- Ecometics, Inc.
- NDC code
- 59365-6064-0
- Origin
- CT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1102-2023
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
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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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