Why it was recalled
Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
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.
Lot numbers, UPCs & expiration codes
Lot: IOHE2.420221128, Exp. 12/7/2022
Where it was sold
BayCare Health System hospitals in FL
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0086-2023
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 1, 2022
- FDA report date
- Dec 21, 2022
- Quantity
- 250 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
Original FDA data
Every field from FDA enforcement report D-0086-2023, exactly as published.
Show all FDA fields
- City
- Temple Terrace
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 91283
- Address
- 7802 E Telecom Pkwy
- Code information
- Lot: IOHE2.420221128, Exp. 12/7/2022
- Postal code
- 33637-0928
- Report date
- Dec 21, 2022
- Product type
- Drugs
- Recall number
- D-0086-2023
- Classification
- Class I
- Recalling firm
- BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
- Product quantity
- 250 syringes
- Termination date
- Mar 15, 2024
- Reason for recall
- Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- BayCare Health System hospitals in FL
- Recall initiation date
- Dec 1, 2022
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Dec 22, 2022