Class I
Terminated
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.
- Company
- Quva Pharma, Inc.
- Recall Initiated
- March 30, 2016
- Posted
- July 13, 2016
- Recall Number
- D-1066-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 20 cases
- Firm Location
- Sugar Land, TX, United States
Reason for Recall
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.
Distribution
CA
Lot / Code Info
Lot #: 14312-0, Exp 4/15/2016
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