Hospira Recalls One Lot Bupivacaine Hydrocloride Injection, USP

Posted on Aug 18, 2016

Hospira, Inc, of Lake Forest, IL, is voluntarily recalling one lot of 0.25% bupivacaine hydrochloride injection, USP due to the presence of particulate matter within a single vial. The issue was identified through a confirmed complaint. The recall affects National Drug Code number 0409-1159-02 and lot number 59-064-DK with the expiry date of November 1, 2017. The lot was distributed nationwide in the United States to wholesalers and hospitals between December 2015 and January 2016. The product is packaged as 50 units of 30 mL single-use tear-top vials per case (25 bottles per tray, two trays per case). To date, Hospira has not received reports of any adverse events associated with the recall. The press release posted to FDA’s website states that anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. Adverse reactions or quality problems may be reported to Food and Drug Administration’s (FDA’s) MedWatch Safety Information and Adverse Event Reporting Program