Drug recall lawyers at Pintas & Mullins Law Firm announce that the FDA recently recalled several lots of injectable antibiotics due to metal, cotton, and hair contamination. The antibiotics, Maxipime (cefepime) and dextrose, are commonly used to treat pneumonia, as well as skin, abdominal, and urinary tract infections.
The antibiotics are manufactured by B. Braun Medical and distributed to hospitals, medical clinics, pharmacies, and suppliers throughout the country. The recalled drugs were shipped between early February and March 2013, with lot number H3A744.
The FDA warned patients that the metal, cotton and hair particles were visible in glass vials and could cause severe health problems if injected. Patients could experience damaging and potentially life-threatening blood clots, heart attacks, and strokes if administered contaminated drugs. Patients implanted with a right to left cardiac shunt may experience respiratory failures, tissue death, or loss of kidney function. Should any patient experience problems with B. Braun’s antibiotics, they should report their injuries to the FDA’s MedWatch Adverse Event Reporting program.
Maxipime is typically administered to patients while in the hospital; in June 2012, the FDA updated the drugs’ safety labels to include the increased risk of seizure in patients with damaged kidneys. This effort was taken after extensive research was documented in medical journals. Fortunately, the majority of patients were able to reverse the seizures after stopping Maxipime and/or after undergoing dialysis. It is worth noting that nearly 70% of patients who experienced seizures were female.
One study, published in 2009, suggested that patients taking Maxipime had higher rates of death than those taking other similar antibiotics. The FDA consequently launched an investigation into the matter, which took much longer than expected due to the large number of studies to review.
In related recall news, Drager recently recalled several Fabius anesthesia machines after it failed to pass the high voltage test. Investigators determined that power supply units from one particular batch were not well maintained. Such an issue could cause the automatic ventilation function of the device to fail, leading to audible and visual alarm.
Baxter also recently recalled two lots of its Dual Luer Lock Caps due to the presence of loose particulate matter in the packaging. The affected lots are 10043 and 10044, with a Product Code of 2C6250. Like the FDA warned for the antibiotic contamination, loose particulate matter in these devices may enter the fluid path of the caps, resulting in severe adverse events such as stroke, pulmonary embolism, and heart attacks.
Dual Luer Lock Caps are used to protect access points on certain medical
devices, such as IV sets, to prevent the entry of foreign matter. The
presence of foreign matter in the caps themselves, however, could introduce
the matter directly into a patient’s cardiovascular system. The
recalled lots were distributed between June 19 and August 20, 2013.
Baxter is providing credits for all affected lots of the caps, and the FDA urges healthcare professionals and patients to report any adverse side effects to the above-linked MedWatch Safety Information program. Recalled products should be removed from facilities and returned to Baxter.
Defective medical device lawyers at Pintas & Mullins Law Firm have decades of experience litigating these types of cases and have earned an esteemed reputation in pharmaceutical litigation. We offer our clients unique resources and personalized support throughout the legal process, and provide free initial consultations to potential clients from all 50 states.