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.
What this means for you
Illness, injury, or structural failure has been reported. 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, Su
- 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.
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