Reported Dec 21, 2022 · 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…
BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy · 7802 E Telecom Pkwy · Temple Terrace, FL · 33637-0928
Is this the product you have?
- 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 codes and dates
- Lot
IOHE2.420221128Exp. 12/7/2022
- Lot
- Amount recalled
- 250 syringes
Where it was sold
Why it was recalled
Stop using this product now
Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Using this product could cause serious injury, illness or death — stop using it now.
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