The Recall Desk
ModerateFDA (Drugs)·D-1422-2014·Announced 2014-07-16

Healix Recalls Bupivacaine HCl Bags Due to Particulate Matter

Healix Infusion Therapy is recalling 10 bags of BUPivacaine HCl 0.25% in On-Q C-bloc bags distributed in Texas due to visible particles.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves particulate matter without reported injuries or illnesses, fitting the criteria for a moderate severity rating.

Plain-English summary

Healix Infusion Therapy, Inc. is recalling 10 bags of BUPivacaine HCl 0.25% Preservative Free (2.5 mg/mL) 500 mL in On-Q C-bloc (2-14 mL/hr) bags. The affected product is identified by Lot # 6156-0 and an expiration date of 03/07/14. The product was distributed in Texas.

The recall was initiated because the bupivacaine HCl injection used to compound this specific lot was recalled by the supplier. This action followed a customer complaint regarding visible particles embedded in the glass vial of the source material.

Consumers and healthcare providers should stop using the affected product and contact Healix Infusion Therapy, Inc. for further instructions or a return.

The recalled product

Product
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.
Manufacturer
Healix Infusion Therapy, Inc.
Category
Drug — Injectable Anesthetic
Hazard
Affected units
10

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 (2)

  • Lot #: 6156-0
  • Exp 03/07/14

Distribution

Distributed in 1 state:

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