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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 6156-0, Exp 03/07/14
Where it was sold
Texas
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1422-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 13, 2014
- FDA report date
- Jul 16, 2014
- Quantity
- 10 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Healix Infusion Therapy, Inc.
Original FDA data
Every field from FDA enforcement report D-1422-2014, exactly as published.
Show all FDA fields
- City
- Sugar Land
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 68304
- Address
- 1075 W Park One Dr
- Code information
- Lot #: 6156-0, Exp 03/07/14
- Postal code
- 77478-2576
- Report date
- Jul 16, 2014
- Product type
- Drugs
- Recall number
- D-1422-2014
- Classification
- Class II
- Recalling firm
- Healix Infusion Therapy, Inc.
- Product quantity
- 10 bags
- Termination date
- Feb 16, 2016
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Texas
- Recall initiation date
- Feb 13, 2014
- Initial firm notification
- Letter
- Center classification date
- Jul 7, 2014