Why it was recalled
Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.
Product description
fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale, Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8015-04
Lot numbers, UPCs & expiration codes
Lot 7257-0 Exp. 08/14
Where it was sold
Texas and Georgia
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-1555-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 27, 2014
- FDA report date
- Aug 27, 2014
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Healix Infusion Therapy, Inc.
Original FDA data
Every field from FDA enforcement report D-1555-2014, exactly as published.
Show all FDA fields
- City
- Sugar Land
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 69056
- Address
- 1075 W Park One Dr Suite 200
- Code information
- Lot 7257-0 Exp. 08/14
- Postal code
- 77478-2576
- Report date
- Aug 27, 2014
- Product type
- Drugs
- Recall number
- D-1555-2014
- Classification
- Class II
- Recalling firm
- Healix Infusion Therapy, Inc.
- Termination date
- Aug 25, 2015
- Reason for recall
- Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale, Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8015-04
- Distribution pattern
- Texas and Georgia
- Recall initiation date
- Jun 27, 2014
- Initial firm notification
- Letter
- Center classification date
- Aug 21, 2014