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FDAMarch 30, 2016drug

PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe, packaged in 24 syringes per case, Rx only, Healix Infusion Therapy Inc, 1075 W Park One Drive, Suite 200, Sugar Land Texas 77478, Product Code: 75901-1205-35.

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

The hazard

Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are incorrectly labeled as .4 mg/10 mL (40 mcg/ml) on the light protective overwrap of each syringe.

What to do

FDA enforcement status: Terminated

Brands named

quva pharmaquva

UPCs

75901120535

Recall history

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

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