FDA recall D-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

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.

Distribution

Texas and Georgia

Key facts

Status

Terminated

Initiation date

2014-06-27

Report date

2014-08-27

Termination date

2015-08-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sugar Land, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1555-2014