Mold contamination caused Hospira to initiate a voluntary recall of one of their injections, adding to the list of manufacturing problems at the company. Hospira is recalling Lactated Ringer and 5% Dextrose Injection products.
What Is Lactated Ringer And 5% Dextrose Injection Products?
Lactated Ringer’s solution is basically a blood replacement. So the common consumer will not have much contact with this product outside of a hospital. However, it is important that consumers be aware that this problem exists.
The recall of Hospira’s Lactated Ringer injection is due to one confirmed customer report where a leak was identified in the primary container between the cobra cap and fill-tube seal and mold was noted in the solution.
According to the FDA, 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 life threatening septic shock. Signs and symptoms could include injection site reactions, fever, shortness of breath, fast heart rate and feeling generally ill with nausea and vomiting.This is just one of the mounting manufacturing issues that Hospira seems to be having lately. As, in August, as we reported, the company recalled some of its Carpujects of hydromorphone after a user discovered one that had been overfilled. The month before that it recalled 19 lots of a variety of drugs in the U.S., as well as some internationally, after glass particles were found in some vials–a problem it laid off on its glass supplier. The company has spent most of this year upgrading plants in Austin, TX, and Clayton and Rocky Mount, NC, trying to get on top of it’s manufacturing issues.