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.
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 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 866-299-4826,
- Manufacturer
- Healix Infusion Therapy, Inc.
- Category
- Drug — Compounded Infusion
- 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
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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