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Recall Observatory FDA recall evidence

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

December 01, 2022

Class I

Product summary

Firm
BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
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

    reason.labeling_packaging · v1.0.0

    mislabeled