February 2014 FDA Recall Drug by Healix Infusion Therapy, Inc.
D-1422-2014 - Presence of Particulate Matter

This Class II drug recall was voluntarily initiated by Healix Infusion Therapy, Inc. on February 13, 2014 for the product Drug. The FDA reported the reason for recall as presence of particulate matter. The product was distributed in Texas and the recall is currently terminated.

Recall Number: D-1422-2014

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.
Initiated
02-13-2014
Reported
07-16-2014
Quantity
10 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68304
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Healix Infusion Therapy, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Texas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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