More Hospira Recalls Issued, Including IV Bags, GemStar Infusion System

Hospira, Inc. has issued a recall for 15 lots of Pipercillin and Tazobactam injection fluids, as well as a recall for the GemStar Infusion System, due to a risk of problems that may cause serious adverse health consequences and possibly even death.  

A GemStar Infusion System Class I recall was announced by the FDA on April 26, due to a risk that the lithium battery voltage level may malfunction if the voltage level drops below 2.4 volts.

When the voltage level drops below 2.4, an error will read “11/004” on the display screen and the device become inoperable. This error renders the machine to delay and interrupt therapy sessions and will also erase all settings and event history.

On the same day, the FDA posted notice of a Piperacillin and Tazobactam recall after visible particles were identified in the solution large enough to cause health problems for patients. Both the drugs and the infusion system are distributed by Hospira, Inc.

The recalls come following a series of manufacturing and quality control problems by Hospira, which have also resulted in other recalls in recent months.

Gemstar Infusion System Malfunctions

The Gemstar recall was issued due to a malfunction that causes an increased risk to patients with more severe conditions because a delay or interruption in therapy. The malfunction could potentially cause significant injury or death to a patient, and healthcare providers are encouraged to use an alternative product when administering critical therapy to patients with severe conditions.

The recalled Gemstar Infusion System models included in the recall are model numbers 13000, 13100, 13150, 13086, 13087, and 13088. The systems were manufactured and distributed by Hospira Inc. from February 1999 through April 2013 to healthcare professionals nationwide.

Healthcare professionals  with recalled GemStar Systems should contact Hospira Advanced Knowledge Center at 1-800-241-4002 for technical assistance and contact  Stericycle at 1-877-907-7516 to obtain a copy of a reply form to fill out and return to the manufacturer. Consumers are also encouraged to replace the lithium batteries in the GemStar systems if they are three years or older.

Pipercillin and Tazobactam Problems

The recalled Pipercillin and Tazobactam injection fluid injections are used to treat mild to severe infections for specified conditions such as appendicitis, uncomplicated and complicated skin infections, pelvic inflammatory disease, and various types of pneumonia. The fluids may show precipitation or crystallization in IV bags or IV lines being administered into patients, posing adverse consequences to patients due to the large sizes of the particles.

The recall consists of Piperacillin and Tazobactam, USP 40.5 grams injection fluid with NDC number 605050773-00 and UPC number 360505077304. The recalled Hospira injection fluids were packaged in 300 mL glass vials for reconstitution and were distributed nationwide to wholesalers, distributors, HMO’s, home infusion and long term care service providers.

For a full list of recalled Piperacillin and Tazobactam lot numbers and expiration dates consumers may visit http://www.fda.gov/Safety/Recalls/ucm349976.htm

Hospira is asking that anyone with existing recalled Piperacillin and Tazobactam injection fluids inventory to stop using and distributing the product and quarantine the recalled lots immediately. Those consumers should contact GENCO at 1-877-674-2078 to arrange a return. For medical inquiries, Hospira Medical Communications may be reached at 1-800-615-0187 or by email at medcom@hospira.com.

Hospira Production Problems

The recalls are the most recent in a string of problems with Hospira products. In February the FDA issued a warning letter to the company over quality control issues at its Lake Forest, Illinois, production plant.

The FDA is also investigating the company’s Rocky Mount, North Carolina, factory after repeated problems, and its Clayton, North Carolina plant has just begun manufacturing propofol again after it was temporarily shut down.

Last summer, the company received an FDA warning over its plant in La Aurora de Heredia, Costa Rica, where it manufactures its Symbiq, Plum, Gemstar and Lifecare PCA infusion pumps due to recurring problems.

On April 26, Hospira Inc. recalled one lot of .09% sodium chloride injection following a consumer complaint indicating particulates within the fluid. After further investigations by government health officials, four different contaminants were identified in four tested samples.

In January 2013, Hospira Inc. also announced a recall of Lactated Ringers and 5% Dextrose due to the presence of mold. The fluids are used as a caloric fluid to restore electrolytes and contained a spore-like material later confirmed to be mold.