# FDA recall D-0086-2023

> **BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy** · Class I · drug recall initiated 2022-12-01.

## 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.

## 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

## Key facts

- **Recall number:** D-0086-2023
- **Recalling firm:** BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-12-01
- **Report date:** 2022-12-21
- **Termination date:** 2024-03-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Temple Terrace, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0086-2023

## Citation

> AI Analytics. FDA recall D-0086-2023. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0086-2023. Source: US FDA. Licensed CC0.

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