CLASS I Drug recall · Reported 21 Dec 2022 · FDA Enforcement Report
Iohexol (300 mg Iodine/mL) Iodine/, Total Volume in syringe recalled
BayCare Integrated Service Center, LLC / is recalling Iohexol (300 mg Iodine/mL) Iodine/, Total Volume in syringe, distributed in Florida. The recall was initiated on 1 Dec 2022 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0086-2023
- FDA event ID
- 91283
- Recalling firm
- BayCare Integrated Service Center, LLC /, Temple Terrace, FL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 1 Dec 2022
- FDA classified
- 22 Dec 2022
- Reported
- 21 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
- Drug class
- Injectable & IV Drugs
Timeline
| 1 Dec 2022 | Recall initiated by company | |
| 21 Dec 2022 | Published in enforcement report | +20 days |
| 22 Dec 2022 | Classified by FDA | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Product as listed by the FDA
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.
Where it was distributed
BayCare Health System hospitals in FL
Questions about this recall
Why was it recalled?
Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Which lots are affected?
Lot: IOHE2.420221128, Exp. 12/7/2022
Where was it sold?
BayCare Health System hospitals in FL
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from BayCare Integrated Service Center, LLC /
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Norepinephrine bitartrate 16 mg in NaCl recalled | BayCare Integrated Service Center, LLC / | Potency & Assay | FL |
| Drug | CLASS II | Succinylcholine Chloride 100 mg/ (20 mg/mL) Syringes recalled | BayCare Integrated Service Center, LLC / | Sterility | FL |
Other Iohexol ( Iodine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Iohexol 200mg Iodine/ML Injectable recalled by Franck's Lab Inc., d.b.a. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Sterility | Nationwide |