Reported Jul 13, 2016 · Terminated
PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe, packaged in 24 syringes per case, Rx…
QuVa Pharma, Inc.
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: QuVa Pharma, Inc. · 1075 W Park One Dr Ste 100 · Sugar Land, TX · 77478-2576
Is this the product you have?
- 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 Code75901-1205-35
- Lot codes and dates
Lot #: 14312-0Exp 4/15/2016
- Amount recalled
- 20 cases
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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