Hospira, the leader of sterile injectable drugs, has discovered problems with multiple lots of its drugs and one of its medical products. In the last few weeks, Apotex, the company who markets Hospira’s products, has issued two nationwide recalls: one for Piperacillin and Tazobactum for injection and the other for Hospira’s GemStar Infusion System. Both the company and the FDA have alerted health care providers of the issues.
On April 29, the FDA announced a Class I recall of the GemStar Infusion System. The device is used for intravenous, arterial, subcutaneous, short-term infusion and parenteral administration of general IV fluids and medications. Patients can use the device at home or in the hospital, as the system is small and lightweight. According to the recall, however, the lithium battery voltage may drop below 2.4 volts and interrupt the system operations. The disruption also can delay the patient’s therapy, which can result in significant injury or death, depending on the patient’s condition.
During the following week, Apotex issued another recall on behalf of Hospira for 21 lots of Piperacillin and Tazobactam for Injection. Although the company had originally recalled 15 lots, the FDA added another six lots on May 10. The drugs, which are used to treat severe infections, can potentially show precipitation/crystallization in the IV bag or IV line after reconstitution. As a result patients may suffer from phlebitis, renal impairment, end-organ embolism and ischemia. Additionally, patients may not get the proper treatment for infection, which can potentially lead to minor or permanent impairment of the body structure or function.
Patients who use the GemStar Infusion System may want to consider use of another product if a delay or interruption in the therapy can result in significant injury or death. The internal AA batteries and battery compartments should be inspected for signs of leakage, corrosion, or other damage prior to each use to ensure that the power remain on. If an individual notices damage caused by leaking batteries, they can return it to Hospira for repair.
Hospira is investigating the cause of the problems with Piperacillin and Tazobactam. Health care providers and customers who have the recalled product should immediately stop use and distribution, quarantine the recalled lots immediately and call GENCO at 1-877-674-2078 to schedule product return.