Home / Recalls / Healix Infusion Therapy, Inc. / D-1555-2014

D-1555-2014 Class II Terminated

Recalled by Healix Infusion Therapy, Inc. — Sugar Land, TX

FDA drug recall D-1555-2014 was initiated by Healix Infusion Therapy, Inc. on June 27, 2014 and is designated Class II. 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. The recall status is terminated (terminated August 25, 2015).

Recall Details

Product Type: Drugs
Report Date: August 27, 2014
Initiation Date: June 27, 2014
Termination Date: August 25, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity

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

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 Pattern

Texas and Georgia

Code Information

Lot 7257-0 Exp. 08/14

Other recalls by Healix Infusion Therapy, Inc.

D-1553-2014 Class II — fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chloride (June 27, 2014)
D-1551-2014 Class II — fentaNYL 1500 mcg/30 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG For (June 27, 2014)
D-1554-2014 Class II — fentaNYL 2750 mcg/55 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG, For (June 27, 2014)
D-1552-2014 Class II — fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in flexable bag, CO (June 27, 2014)
D-1422-2014 Class II — BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-14 (February 13, 2014)