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.
Iopamidol 41% Injectable 198 Ml 99 Ml 50 Ml 600 Ml 72 Ml
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
What was recalled
IOPAMIDOL 41% INJECTABLE 198 ML 99 ML 50 ML 600 ML 72 ML; IOHEXOL, 4ML VIAL 240MG IODINE/ML INJECTABLE 200 ML; IOHEXOL, 3ML VIAL 300MG IODINE/ML INJECTABLE 180 ML 600 ML 90 ML 900 ML (2 DIFFERENT PRODUCTS)
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1549-2012
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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