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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 14312-0, Exp 4/15/2016
Where it was sold
CA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1066-2016
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 30, 2016
- FDA report date
- Jul 13, 2016
- Quantity
- 20 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- QuVa Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-1066-2016, exactly as published.
Show all FDA fields
- City
- Sugar Land
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 73710
- Address
- 1075 W Park One Dr Ste 100
- Code information
- Lot #: 14312-0, Exp 4/15/2016
- Postal code
- 77478-2576
- Report date
- Jul 13, 2016
- Product type
- Drugs
- Recall number
- D-1066-2016
- Classification
- Class I
- Recalling firm
- QuVa Pharma, Inc.
- Product quantity
- 20 cases
- Termination date
- Nov 29, 2016
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- CA
- Recall initiation date
- Mar 30, 2016
- Initial firm notification
- Center classification date
- Jul 6, 2016