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FDADecember 1, 2022drug

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 organical...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL

What to do

FDA enforcement status: Terminated

Brands named

baycare integrated service center llc dba baycare central pharmacybaycarebaycare integrated

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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