Healix Recalls Fentanyl Infusion Bags Due to Sterility Concerns
Healix Infusion Therapy is recalling 48 bags of compounded fentanyl in Texas and Georgia because the supplier recalled the source drug 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, which corresponds to a Severe severity score under the rubric, particularly given the risk of infection associated with a lack of sterility assurance.
Plain-English summary
Healix Infusion Therapy, Inc. is recalling 48 bags of fentanyl 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride. The affected product is a compounded drug intended for institutional or office use only. The specific lots involved are 7230-0 and 7269-0, both 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 resulted in a lack of assurance of sterility for the compounded infusion bags.
The affected product was distributed in Texas and Georgia. Because this is a compounded drug for institutional or office use, it is not intended for direct consumer purchase. Healthcare facilities and offices that may have received these specific lots should stop using the product and contact the recalling firm for instructions.
The recalled product
- Product
- fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in 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
- Affected units
- 48
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 (2)
- Lots 7230-0
- 7269-0 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.
See all 5 products in this recall →Related recalls
Same manufacturer · Healix Infusion Therapy, Inc.
See all →- SevereHealix Recalls Fentanyl Infusion Bags Due to Sterility Concerns
FDA (Drugs) · 2014-08-27
- SevereHealix Recalls Fentanyl Syringes Due to Sterility Concerns
FDA (Drugs) · 2014-08-27
- SevereHealix Recalls Fentanyl Syringes Due to Sterility Concerns
FDA (Drugs) · 2014-08-27
- SevereHealix Recalls Fentanyl and Ropivacaine Infusion Bags Due to Sterility Concerns
FDA (Drugs) · 2014-08-27
- ModerateHealix Recalls Bupivacaine HCl Bags Due to Particulate Matter
FDA (Drugs) · 2014-07-16
Same hazard · sterility
See all →- SevereK.C. Pharmaceuticals Recalls Target Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- HighFentanyl Injection Bags Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2023-10-11
- HighFentanyl injectable product recalled for lack of sterility assurance
FDA (Drugs) · 2023-10-11
- HighFentanyl Injectable Solution Recalled Over Sterility Concerns
FDA (Drugs) · 2023-10-11
- HighFentanyl Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-08-09
- HighFentanyl Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2023-10-11
- HighFDA Recalls Fentanyl Injectable for Lack of Sterility Assurance
FDA (Drugs) · 2023-10-11