Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride Recalled by QuVa Pharma, Inc. Due to Labeling: Label Error on Declared Strength. Product has...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact QuVa Pharma, Inc. directly.
Affected Products
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.
Quantity: 20 cases
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 1 state: CA
About QuVa Pharma, Inc.
QuVa Pharma, Inc. has 37 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report