Drug product
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.
D-0086-2023
Product summary
- Event
- Event 91283
- Status
- Terminated
- Classification
- Class I
- Quantity
- 250 syringes
- Official record key
drug-enforcement:D-0086-2023
Official wording
Reason: Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Code information: Lot: IOHE2.420221128, Exp. 12/7/2022
Distribution pattern: BayCare Health System hospitals in FL
Derived failure modes
-
Labeling or packaging
mislabeled