CLASS II Drug recall · Reported 27 Aug 2014 · FDA Enforcement Report
fentaNYL 200 mcg/ (2 mcg/mL) and Ropivacaine recalled
Healix Infusion Therapy is recalling fentaNYL 200 mcg/ (2 mcg/mL) and Ropivacaine 2% in 9% Sodium Chloride, in flexable, distributed in Georgia, Texas. The recall was initiated on 27 Jun 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1553-2014
- FDA event ID
- 69056
- Recalling firm
- Healix Infusion Therapy, Sugar Land, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jun 2014
- FDA classified
- 21 Aug 2014
- Reported
- 27 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 27 Jun 2014 | Recall initiated by company | |
| 21 Aug 2014 | Classified by FDA | +55 days |
| 27 Aug 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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, 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8007-02
Where it was distributed
Texas and Georgia
Questions about this recall
Is fentaNYL 200 mcg/ (2 mcg/mL) and Ropivacaine 2% in 9% Sodium Chloride, in flexable recalled?
Yes. Healix Infusion Therapy recalled fentaNYL 200 mcg/ (2 mcg/mL) and Ropivacaine 2% in 9% Sodium Chloride, in flexable on 27 Jun 2014. The recall is Class II and its status is Terminated. Recall number D-1553-2014.
Why was it recalled?
Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.
Which lots are affected?
Lot 7250-0 Exp. 08/14
Where was it sold?
Texas and Georgia
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Healix Infusion Therapy
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | fentaNYL 2750 mcg/ (50 mcg/mL) in prefilled syringe recalled | Healix Infusion Therapy | Sterility | GA, TX |
| Drug | CLASS II | fentaNYL 2500 mcg/ (10 mcg/mL) in 9% Sodium Chloride recalled | Healix Infusion Therapy | Sterility | GA, TX |
| Drug | CLASS II | fentaNYL 1500 mcg/ (50 mcg/mL) in prefilled syringe recalled | Healix Infusion Therapy | Sterility | GA, TX |
| Drug | CLASS II | fentaNYL 5000 mcg/ (20 mcg/mL) in 9% Sodium Chloride recalled | Healix Infusion Therapy | Sterility | GA, TX |
| Drug | CLASS II | BUPivacaine HCl 25% Preservative Free 5 mg/mL) recalled | Healix Infusion Therapy | Particulate Matter | TX |