Recalls / Class II
Class IID-1553-2014
Product
fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chloride 100mL, in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc., at 866-299-4826, 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8007-02
- Affected lot / code info
- Lot 7250-0 Exp. 08/14
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.
Recalling firm
- Firm
- Healix Infusion Therapy, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1075 W Park One Dr Suite 200, Sugar Land, Texas 77478-2576
Distribution
- Quantity
- 12 bags
- Distribution pattern
- Texas and Georgia
Timeline
- Recall initiated
- 2014-06-27
- FDA classified
- 2014-08-21
- Posted by FDA
- 2014-08-27
- Terminated
- 2015-08-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1553-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.