Class III · Low risk
Iohexol (300 mg Iodine/mL)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes packaged in a bag labeled as Omnipaque (iohexol) 300 mg I/mL, 2.4g Iodine/8 mL in a 10 mL syringe, Compounded with GE Healthcare product, Each mL contains (647 mg) of iohexol as 300 mg of organically bound iodine, 1.21 mg tromethamine, and 0.1 mg edetate calcium disodium, For Injection or oral use; Rx Only, BayCare Central Pharmacy, 7802 Telecom Parkway, Temple Terrace, FL 33637.
Drug: Iodine
- Recalling firm
- BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0086-2023 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Iodine recalls
See all
Class I · High risk
Optiray Imaging Bulk Package-350
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Class II · Moderate risk
BD PurPrep
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
Povi-One
sub potency
Class II · Moderate risk
BD PurPrep
Lack of assurance of Sterility: potential product contamination
Other recalls by BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
All 2022 recalls
Class III · Low risk
Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%
Subpotent drug
Class II · Moderate risk
Succinylcholine Chloride 100 mg/5 mL
Lack of sterility assurance
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