Recalls / Class I
Class ID-1066-2016
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Affected lot / code info
- Lot #: 14312-0, Exp 4/15/2016
Why it was 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.
Recalling firm
- Firm
- QuVa Pharma, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1075 W Park One Dr Ste 100, N/A, Sugar Land, Texas 77478-2576
Distribution
- Quantity
- 20 cases
- Distribution pattern
- CA
Timeline
- Recall initiated
- 2016-03-30
- FDA classified
- 2016-07-06
- Posted by FDA
- 2016-07-13
- Terminated
- 2016-11-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1066-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.