Home >  News >  July, 2014

Tainted Lot of Marcaine Recalled by Hospira

Customer noticed particulate in the solution.

Published: July 1, 2014

A recall of one lot of Marcaine (bupivacaine) has been initiated by Hospira, after a customer reported seeing particulate embedded in a glass vial and in the solution.

The affected lot (0.5% Marcaine [Bupivacaine HCl Injection, USP], 30 mL, Single-dose Vial — Preservative Free [NDC 0409-1560-29], Lot 33-545-DD) was distributed between November 2013 and March 2014 to wholesalers/distributors, hospitals and clinics nationwide.

If the particulate is administered to a patient, it could block administration and cause a delay in therapy. However, the identified particulate is so small, it's more likely to pass through the catheter and cause inflammation, mechanical disruption of tissue or immune response, says the company. There's also an extremely unlikely possibility that if exposed to a strong magnetic field, such as an MRI, the particulate could dislodge and cause tissue damage.

Hospira says it hasn't received any reports of adverse effects associated with the lot, and that the problem is the result of a supplier's glass defect.

The affected product should immediately be pulled and quarantined, says Hospira, which is issuing recall letters to customers and distributors and arranging for it to be returned to Stericycle, which can be reached at 1-888-656-6380.

Jim Burger


Also in the News...

Anesthesia Group Must Pay Up After Patient Bleeds Out in Recovery
Did Hospital Ignore Contaminated Scopes and Infected Patients?
AmSurg, Envision Healthcare Merge to Form Physician Staffing Giant
Obesity Device Drains a Portion of Stomach Contents After Meals Into the Toilet
Hospitals Will Likely Soon Be Required to Have Antibiotic-Stewardship Programs
U. of Louisville Hospital Now Unsafe, Vice Chair of Surgery Insists
Suit: Pedicle Screw Left in Patient's Body for 2 Days After Surgery

New to Outpatient Surgery Magazine?
Sign-up to continue reading this article.
Register Now
Have an account? Please log in:
Email Address:
  Remember my login on this computer

advertiser banner

Other Articles That May Interest You

Get the Most Out of Your Malignant Hyperthermia Drills

11 tips to help make sure you're prepared for the worst.

Make Sure Your Pre-Surgical Checklists Are Followed

American College of Surgeons Releases Guidelines on Double-Booking Surgeries

ACS says "overlapping operations" are OK, but patients should be informed.