Iohexol — Class I drug recall D-0086-2023
Terminated recall by BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy, reported 2022-12-21, distributed in FL. Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg i
| Recall number | D-0086-2023 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy, Temple Terrace, FL, United States |
| Recall initiated | 2022-12-01 |
| Classified | 2022-12-22 |
| Reported by FDA | 2022-12-21 |
| Terminated | 2024-03-15 |
| Distributed | FL |
| Quantity | 250 syringes |
| Reason classes | labeling, potency |
| Lot numbers | IOHE2.420221128 |
| Expiration dates | 2022-12-07 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0086-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.