BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy: Drug Recall

Recall #D-0086-2023 · 12/01/2022

Class I: Dangerous

Recall Details

Recall Number: D-0086-2023
Classification: Class I
Product Type: Drug
Recalling Firm: BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
Status: Terminated
Date Initiated: 12/01/2022
Location: Temple Terrace, FL, United States
Voluntary/Mandated: Voluntary: Firm initiated
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

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.

Distribution Pattern

BayCare Health System hospitals in FL

Other Recalls by BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy

Class III: Low Risk 02/14/2022

Subpotent drug
Class II: Risk 07/30/2021

Lack of sterility assurance

View all recalls by BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.