CLASS II Drug recall · Reported 16 Jul 2014 · FDA Enforcement Report

BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) recalled

Healix Infusion Therapy is recalling BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) in On-Q C-bloc (2-/hr), Healix, distributed in Texas. The recall was initiated on 13 Feb 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 6156-0, Exp 03/07/14

Quantity recalled10 bags

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-1422-2014
FDA event ID: 68304
Recalling firm: Healix Infusion Therapy, Sugar Land, TX
Classification: Class II
Status: Terminated
Recall initiated: 13 Feb 2014
FDA classified: 7 Jul 2014
Reported: 16 Jul 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Drug class: Injectable & IV Drugs

Timeline

13 Feb 2014	Recall initiated by company
7 Jul 2014	Classified by FDA	+144 days
16 Jul 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Presence of Particulate Matter: The bupivacaine HCl injection used to compound this lot of BUPivacaine HCl 0.25% Preservative Free 500 mL in On-Q C-bloc was recalled by the supplier due to a customer complaint of visible particles embedded in the glass vial.

Product as listed by the FDA

BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-14 mL/hr) bag, Healix Infusion Therapy, Inc., 1075 West Park One Drive, Suite 200, Sugar Land, Texas 77478, NDC 75901-7210-53.

Where it was distributed

Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot #: 6156-0, Exp 03/07/14

Where was it sold?

Texas

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 26 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
27 Aug 2014Drug	CLASS II	fentaNYL 200 mcg/ (2 mcg/mL) and Ropivacaine recalled	Healix Infusion Therapy	Sterility	GA, TX
27 Aug 2014Drug	CLASS II	fentaNYL 2750 mcg/ (50 mcg/mL) in prefilled syringe recalled	Healix Infusion Therapy	Sterility	GA, TX
27 Aug 2014Drug	CLASS II	fentaNYL 2500 mcg/ (10 mcg/mL) in 0.9% Sodium Chloride recalled	Healix Infusion Therapy	Sterility	GA, TX
27 Aug 2014Drug	CLASS II	fentaNYL 1500 mcg/ (50 mcg/mL) in prefilled syringe recalled	Healix Infusion Therapy	Sterility	GA, TX
27 Aug 2014Drug	CLASS II	fentaNYL 5000 mcg/ (20 mcg/mL) in 0.9% Sodium Chloride recalled	Healix Infusion Therapy	Sterility	GA, TX

Other Bupivacaine Preservative Free recalls

All 9

Reported	Class	Recall	Company	Reason	Where
27 Jul 2016Drug	CLASS II	0.125% Bupivacaine HCl (Preservative Free) recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016Drug	CLASS II	0.03% Bupivacaine HCl (Preservative Free) recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016Drug	CLASS II	0.5% Bupivacaine HCl (Preservative Free) recalled by Pharmedium Services	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016Drug	CLASS II	0.0625% Bupivacaine HCl (Preservative Free) recalled	Pharmedium Services	Particulate Matter	Nationwide
27 Jul 2016Drug	CLASS II	0.25% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride recalled	Pharmedium Services	Particulate Matter	Nationwide