Injectable iohexol syringes recalled for mislabeled iodine strength
BayCare Integrated Service Center is recalling 250 iohexol injection syringes mislabeled as 300 mg iodine/mL but actually containing 350 mg iodine/mL. The labeling error could result in dosing mistakes.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification for this pharmaceutical recall establishes a minimum severity score of 4. The dosing discrepancy—350 mg iodine per mL mislabeled as 300 mg—presents a significant risk of medication administration errors, even though no illnesses or injuries have been reported.
Plain-English summary
BayCare Integrated Service Center, LLC (dba BayCare Central Pharmacy) is recalling 250 syringes of iohexol injection, a contrast medium used in medical imaging. The syringes were labeled as containing 300 mg iodine per mL but actually contain 350 mg iodine per mL. The affected product is Lot IOHE2.420221128 with an expiration date of 12/7/2022.
The labeling discrepancy poses a risk of dosing errors if healthcare providers rely on the incorrect label when calculating and administering the contrast media. Patients could receive unintended higher iodine doses than prescribed or ordered by their physician.
The recalled syringes were distributed to BayCare Health System hospitals in Florida. Healthcare facilities should immediately discontinue use of affected syringes and not administer any product from the identified lot number.
Patients who received doses from affected syringes should contact their healthcare provider for medical guidance and advice regarding any necessary follow-up care.
The recalled product
- 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…
- Affected units
- 250
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: IOHE2.420221128
- Exp. 12/7/2022
Distribution
Distributed in 1 state:
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