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Healix Infusion Therapy, Inc.

Complete recall history across all FDA and CPSC categories — 6 total recalls

Healix Infusion Therapy, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (6)

FDA drug safety enforcement actions by Healix Infusion Therapy, Inc.

Date Product Reason Class
Jun 27, 2014 fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chlori... Lack of Assurance of Sterility: Firm received fentanyl from a supplier who re... Class II
Jun 27, 2014 fentaNYL 2750 mcg/55 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG, ... Lack of Assurance of Sterility: Firm received fentanyl from a supplier who re... Class II
Jun 27, 2014 fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in flexable bag,... Lack of Assurance of Sterility: Firm received fentanyl from a supplier who re... Class II
Jun 27, 2014 fentaNYL 1500 mcg/30 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG ... Lack of Assurance of Sterility: Firm received fentanyl from a supplier who re... Class II
Jun 27, 2014 fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable ba... Lack of Assurance of Sterility: Firm received fentanyl from a supplier who re... Class II
Feb 13, 2014 BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-... Presence of Particulate Matter: The bupivacaine HCl injection used to compou... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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