FDAFDA · Food and drugs·Recall number D-1422-2014
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.
Published July 16, 2014 · Recall initiated: February 13, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Healix Infusion Therapy, Inc.
- Distributor
- Texas
- Lot
- Lot #: 6156-0, Exp 03/07/14
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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