7 recent drug, device recalls

Medical device and drug recalls, whether voluntary or mandated by the FDA, ensure patient safety. Here are seven that have been reported to the FDA since Sept. 15:

  1. Eli Lilly recalled a lot of its Glucagon Emergency Kit for low blood sugar because of a patient complaint that the vial of glucagon was in liquid form instead of powder form, which may fail to treat severe low blood sugar due to loss of potency. The patient who reported the issue experienced lack of drug effect and had subsequent seizures.

  2. Armstrong Medical Limited recalled its Amsorb Plus pre-filled cans, which contain a chemical substance used in anesthesia machines to absorb carbon dioxide the patient breathes out while under anesthesia. The company received reports that some of the pre-filled cans have difficulties with gas flow that may cause a reduced airflow to the patient. If not addressed, this issue could prevent a ventilator from providing enough breathing assistance to the patient, which could cause a buildup of carbon dioxide in the patient's body and result in negative health effects. There have been no injuries or deaths reported related to the recall.

  3. Cordis recalled its Super Torque angiographic catheter, which is used to visualize and measure parts of the vascular system, because of the potential for the marker bands to move or dislodge during procedures. If this happens, it could cause serious adverse events including heart attack or stroke. There have been 167 complaints, eight injuries and no deaths reported related to the recall.
  4. IntegraDose Compounding Services recalled nine lots of the antibiotic cefazolin because of a lack of sterility assurance. The drugs were compounded in a biologic safety cabinet that hadn't completed dynamic smoke study testing. IntegraDose hasn't received any reports of adverse events related to the recall.

  5. Medtronic recalled a brain aneurysm stent device because of a risk of malfunction that has been linked to 10 serious injuries and two deaths.

  6. Pfizer recalled all lots of its smoking cessation drug Chantix because of the presence of the carcinogen N-nitroso-varenicline at levels above FDA-approved limits.

  7. Smiths Medical recalled its Normoflo irrigation fluid warmer and Normoflo irrigation warming set, which are used for warming blood, blood products and intravenous solutions before use, due to the potential for aluminum ions leaching into the fluids, meaning a patient could be exposed to high levels of aluminum. Exposure to toxic levels of aluminum can cause serious adverse events and death. There have been no complaints, injuries or deaths reported related to the recall. 

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