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...

Duodenoscope With Disposable Distal Cap Said to Be Easier to Reprocess
Who's Using the Robot?
Inmate Claims He Was Needlessly Handcuffed and Shackled During and After Emergency Appendectomy
Editorial: Orthopedists Should Hand in Their Football Sideline Passes
Johnson & Johnson Hit With $57M Judgment in Pelvic Mesh Suit
Feds: Sightpath Lured Eye Surgeons With Luxury Trips for Nearly a Decade
Anatomy of a Scam: Materials Manager and His Accomplice Allegedly Bilked Facility Into Buying Supplies It Never Received

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

Faulty Sensor Leads to Recall of Alaris Syringe Pump

Sensor-related false alarms could interrupt the supply of vital fluids to patients.

Retained Object Removed ... 18 Years Later

Make Sure Nothing's Left Behind in a Patient

Define the roles and responsibilities each team member has in the counting process.