Recalls / Class II

Class IID-1555-2014

Product

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

Affected lot / code info

Lot 7257-0 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

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-1555-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.