Iohexol recalled over labeling errors

Recall date

December 1, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy recalls 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 l…

Recall number

D-0086-2023

FDA classification

Class I

Brand / firm

BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy

Sold / distributed

BayCare Health System hospitals in FL

Why it was recalled

Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

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.