Healix Recalls Fentanyl Syringes Due to Sterility Concerns
Healix Infusion Therapy is recalling 220 fentanyl prefilled syringes because the supplier recalled the drug due to loose or missing vial crimps, raising sterility concerns.
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. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or high-risk scenarios (like sterility failure in injectable drugs) are rated as Severe (4).
Plain-English summary
Healix Infusion Therapy, Inc. is recalling 220 prefilled syringes of fentanyl 2750 mcg/55 mL (50 mcg/mL). The product is a compounded drug intended for institutional or office use only and is not for resale. The recall affects Lots 7083-0, 7202-0, and 7222-0, which have 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 syringes.
The affected product was distributed in Texas and Georgia. Because this is a compounded drug for institutional or office use, it is not typically available to the general public. Healthcare facilities and offices that have received these specific lots should stop using the product and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- fentaNYL 2750 mcg/55 mL (50 mcg/mL) in prefilled syringe, 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…
- Manufacturer
- Healix Infusion Therapy, Inc.
- Category
- Drug — Compounded Injectable
- Affected units
- 220
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 (3)
- Lots 7083-0
- 7202-0
- 7222-0 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
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