Recalls / Class II
Class IID-1422-2014
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.
- Affected lot / code info
- Lot #: 6156-0, Exp 03/07/14
Why it was recalled
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.
Recalling firm
- Firm
- Healix Infusion Therapy, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1075 W Park One Dr, Sugar Land, Texas 77478-2576
Distribution
- Quantity
- 10 bags
- Distribution pattern
- Texas
Timeline
- Recall initiated
- 2014-02-13
- FDA classified
- 2014-07-07
- Posted by FDA
- 2014-07-16
- Terminated
- 2016-02-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1422-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.