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
Product summary
- 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
Particulate Matter