D-0086-2023 Class I Terminated
FDA drug recall D-0086-2023 was initiated by BayCare Integrated Service Center, LLC /Dba BayCare Central Pharmacy on Dec 1, 2022 and is designated Class I. Reason for recall: Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL The recall status is terminated (terminated Mar 15, 2024). Affected quantity: 250 syringes.
Recall details
- Product Type
- Drugs
- Report Date
- Dec 21, 2022
- Initiation Date
- Dec 1, 2022
- Termination Date
- Mar 15, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 250 syringes
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.
Reason for recall
Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Distribution pattern
BayCare Health System hospitals in FL
Code information
Lot: IOHE2.420221128, Exp. 12/7/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0086-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026