Hospira recalls Lactated Ringer’s due to mold contamination
Injectable drugs and infusion technologies leader, Hospira, Inc. announced Friday it is initiating a voluntary user-level recall of one lot of Lactated Ringer’s and 5% Dextrose Injection, USP, 1000 mL, Flexible Container, NDC 0409-7929-09.
The recall was initiated based on one customer report. The container has a leak between the cobra cap and fill-tube seal and a mold-like structure was seen in the solution. The recall is being conducted as a precautionary measure.
According to a Food and Drug Administration Firm Press Release:
When a primary container within an overwrap has a leak, there is an open pathway for contamination of the fluid. The overwrap is not sterile, and any fluid which may have leaked out may become trapped within the overwrap and has the potential to be reintroduced into the primary container. If contaminated solution is used on a patient, critical patient harm may result. Injections of mold could potentially lead to septicemia (blood stream infections), which in a worst-case scenario may have the potential to progress to septic shock, which may be life threatening. Signs and symptoms could include injection site reactions, fever, shortness of breath, fast heart rate and feeling generally ill with nausea and vomiting.
The specific lot of Lactated Ringer’s and 5% Dextrose Injection, USP, 1000 mL, affected by the recall is 12-160-JT with an expiration date of 1 Dec. 2013.
The affected lot was distributed in all the United States with the exception of Alaska, between the dates of January 2012 and June 2012.
There have been no reports of adverse events associated with this product.
Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-877-650-7688 , between the hours of 8am and 5pm EST, Monday through Friday, to arrange for the return of the product. Replacement product from other lots is available.
