Class I
Terminated
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.
- Recall Initiated
- December 1, 2022
- Posted
- December 21, 2022
- Recall Number
- D-0086-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 250 syringes
- Firm Location
- Temple Terrace, FL, United States
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
Lot / Code Info
Lot: IOHE2.420221128, Exp. 12/7/2022
More recalls by Baycare Integrated Service Center, Llc /Dba Baycare Central Pharmacy
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