44 FDA recalls mention Iodine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Iodine.
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…
Reason sub potency
Reason Lack of assurance of Sterility: potential product contamination
Reason Lack of assurance of Sterility: potential product contamination
Reason Subpotent drug
Reason Defective Container: broken or leaking bottles.
Reason Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The…
Reason CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Reason Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Reason cGMP deviations: Temperature abuse
Reason Lack of Assurance of Sterility
Reason Subpotent Drug
Reason SubPotent: Out of Specification
Reason SubPotent: Out of Specification
Reason SubPotent: Out of Specification
Reason SubPotent: Out of Specification
Reason SubPotent: Out of Specification
Reason SubPotent: Out of Specification
Reason Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
Reason Lack of sterility assurance.
Reason Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product…
Reason Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
Reason 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…
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