FDAFDA · Food and drugs·Recall number D-1066-2016
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.
Published July 13, 2016 · Recall initiated: March 30, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- QuVa Pharma, Inc.
- Distributor
- CA
- Lot
- Lot #: 14312-0, Exp 4/15/2016
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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