BETHESDA, MD 18 Jun 2014—Hospira Inc. on June 17 announced the recall of 0.5% Marcaine lot 33-545-DD because of a confirmed report of particulates in the drug solution and embedded in the glass vial.
Vials in the lot contain 30 mL of preservative-free bupivacaine hydrochloride injection.
The company attributed the particulate embedded in the vial to defective glass provided by a supplier.
Vials in lot 33-545-DD were distributed from November 2013 through March 2014, Hospira said.
Direct customers of Hospira should expect to receive a letter about the recall and return of vials in lot 33-545-DD. The company said anyone with a vial from lot 33-545-DD should quarantine and not use it. Questions about the recall process should be directed to Stericycle at 888-656-6380, Monday–Friday 8 a.m. to 5 p.m. Eastern Time.
Hospira did not identify the particulates in the Marcaine glass vial. But in a recall earlier this year of generic preservative-free 0.5% bupivacaine in 30-mL glass vials, the company said it had identified the embedded particulates as iron oxide.