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Recall Observatory FDA recall evidence

Drug 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.

D-1422-2014

February 13, 2014

Class II

Product summary

Firm
Healix Infusion Therapy, Inc.
Event
Event 68304
Status
Terminated
Classification
Class II
Quantity
10 bags
Official record key
drug-enforcement:D-1422-2014

Official wording

Reason: 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.

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

Distribution pattern: Texas

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter