RecallDepth
Class I Terminated

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.

Company
Baycare Integrated Service Center, Llc /Dba Baycare Central Pharmacy
Recall Initiated
December 1, 2022
Posted
December 21, 2022
Recall Number
D-0086-2023
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
250 syringes
Firm Location
Temple Terrace, FL, United States

Reason for Recall

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

Distribution

BayCare Health System hospitals in FL

Lot / Code Info

Lot: IOHE2.420221128, Exp. 12/7/2022

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