RecallDepth
Class II Terminated

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.

Company
Healix Infusion Therapy, Inc.
Recall Initiated
February 13, 2014
Posted
July 16, 2014
Recall Number
D-1422-2014
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
10 bags
Firm Location
Sugar Land, TX, United States

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.

Distribution

Texas

Lot / Code Info

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

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