The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1553-2014·Announced 2014-08-27

Healix Recalls Fentanyl and Ropivacaine Infusion Bags Due to Sterility Concerns

Healix Infusion Therapy is recalling 12 bags of compounded fentanyl and ropivacaine due to a lack of assurance of sterility from a supplier recall.

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 according to the rubric.

Plain-English summary

Healix Infusion Therapy, Inc. is recalling 12 bags of a compounded drug containing fentanyl 200 mcg/100 mL and Ropivacaine 0.2% in 0.9% Sodium Chloride. The product is identified by Lot 7250-0 with an expiration date of 08/14. The recall was initiated because the firm received fentanyl from a supplier who recalled it due to loose or missing fliptop vial crimps, resulting in a lack of assurance of sterility.

The affected product was distributed in Texas and Georgia. It is a compounded drug intended for institutional or office use only and is not for resale. Federal law prohibits dispensing without a prescription.

Consumers and healthcare providers should stop using the affected product and contact Healix Infusion Therapy, Inc. at 866-299-4826 for further instructions.

The recalled product

Product
fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chloride 100mL, in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc., at…
Manufacturer
Healix Infusion Therapy, Inc.
Category
Drug — Compounded Infusion
Hazard
Affected units
12

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 7250-0 Exp. 08/14

Distribution

Distributed in 2 states:

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 →

Same hazard · sterility

See all →

Similar recalls