Hospira Recalls Lot of Marcaine Due to Particulates

Hospira has initiated yet another recall of a drug due to discoloration and visible particulate matter embedded in glass vials. The Monday recall involves one lot of 0.25 percent 10 mL single-dose Marcaine anesthetic distributed to wholesalers, hospitals and clinics in the U.S. between December 2013 and January 2014.

The particulates were found to be iron oxide, Hospira spokesman Daniel Rosenberg told Drug Daily Bulletin, and were attributed to a supplier’s glass defect. The drugmaker is working with its supplier to implement corrective and preventive actions and recommends that customers quarantine affected Marcaine (bupivacaine HCl injection, USP) and notify any potential users.

While no adverse events related to the particulates have been reported, they could block administration of the drug or cause inflammation or immune response, the company said.

Last week, Hospira announced that it was recalling seven lots of another anesthetic, propofol, due to metal particulates in glass vials. In November, the company was hit with a Form 483 for glass particles found in sterile lyophilized drugs during a summer inspection of the company’s McPherson, Kan., manufacturing plant. And the month before that, the drugmaker was forced to recall one lot of 1 percent lidocaine HCl injection, one lot of metoclopramide injection and two lots of odansetron injection because of particulates.

Marcaine is indicated for local or regional anesthesia or analgesia during surgery, diagnostic and therapeutic procedures, and obstetrical procedures. — Lena Freund

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