Drug Enforcement D-0086-2023

Product Information

Product description: 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.
Product quantity: 250 syringes
Reason for recall: Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Recall initiation reason: —
Initial firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution pattern: BayCare Health System hospitals in FL

Recalling firm: BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
Address: 7802 E Telecom Pkwy, N/A

United States
Voluntary / Mandated: Voluntary: Firm initiated
Status date: —