FDA Recall D-0086-2023

BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy · Temple Terrace, FL

Class I — life-threatening Terminated 470 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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.

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

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 record

Recall number: D-0086-2023
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: BayCare Health System hospitals in FL
Recall initiated: 2022-12-01
Classified by FDA Center: 2022-12-22
FDA published: 2022-12-21
Terminated: 2024-03-15
Recalling firm: BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
Firm location: Temple Terrace, FL

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