Healix Recalls Fentanyl Infusion Bags Due to Sterility Concerns
Healix Infusion Therapy is recalling compounded fentanyl infusion bags distributed in Texas and Georgia because the supplier recalled the source fentanyl due to loose or missing vial crimps.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury or property damage (such as sterility issues in IV drugs) are rated as Severe.
Plain-English summary
Healix Infusion Therapy, Inc. is recalling fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexible bag. The product is a compounded drug intended for institutional or office use only and is not for resale. The specific lot affected is Lot 7257-0 with an expiration date of 08/14.
The recall was initiated because the firm received fentanyl from a supplier who recalled the product due to loose or missing fliptop vial crimps. This defect creates a lack of assurance of sterility for the compounded infusion bags. The product was distributed in Texas and Georgia.
Consumers and healthcare facilities should stop using the affected product and contact Healix Infusion Therapy, Inc. at (866) 298-4826 for further instructions.
The recalled product
- 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…
- Manufacturer
- Healix Infusion Therapy, Inc.
- Category
- Drug — Compounded Infusion
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 7257-0 Exp. 08/14
Distribution
Part of a larger recall action
This product is one of 5 recalled by Healix Infusion Therapy, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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