FDA Recall D-1066-2016
QuVa Pharma, Inc. · Sugar Land, TX
Class I — life-threatening Terminated 244 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
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.
Recall record
- Recall number
D-1066-2016- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- CA
- Recall initiated
- 2016-03-30
- Classified by FDA Center
- 2016-07-06
- FDA published
- 2016-07-13
- Terminated
- 2016-11-29
- Recalling firm
- QuVa Pharma, Inc.
- Firm location
- Sugar Land, TX