Lactated Ringers and 5% Dextrose Inj Found to Contain Mold
Hospira announced a voluntary nationwide recall of one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000mL, Flexible Container. This recall is due to a confirmed customer report where a filamentous-like structured particle was found within the solution of the primary container. This particulate was confirmed to be indicative of mold and a puncture in the same location was also confirmed, causing the primary container to leak.
The recalled products have Lot# 35-118-JT, NDC 0409-7929-09 with an expiration date of November 1, 2015. The product was distributed from December 2013 through February 2014.
IV administration of a non-sterile product can result in infections that may be fatal, and may result in prolonged hospitalization or organ failure. Anyone with an existing inventory should stop use and quarantine the product immediately.
For more information call (888) 912-8457 or visit FDA.gov.