Class I โ€” Serious Health Hazard

Serious health hazard โ€” there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Iohexol (300 mg Iodine/mL) Recalled by BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy Due to Mislabeling

Date: December 1, 2022
Company: BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy directly.

Affected Products

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.

Quantity: 250 syringes

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 1 state: FL

Affected (1 state)Not affected

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

BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy has 3 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report