7 recent drug, device recalls

Medical device and drug recalls, whether voluntary or mandated by the FDA, ensure patient safety. Here are seven reported to the FDA since early December:

  1. Apotex recalls blood thinner due to packaging error
    Apotex has recalled two batches of its enoxaparin sodium, a blood thinner, after finding that some syringes were incorrectly labeled as containing a higher strength of the drug.

  2. Chicago drugmaker recalls neuromuscular drug due to labeling error
    Meitheal Pharmaceutical has recalled one lot of cisatracurium, a muscle-relaxing drug used during surgery, after finding that some of the vials in the lot are incorrectly labeled as phenylephrine, a drug used to treat low blood pressure during surgery.

  3. Nostrum Laboratories recalls metformin after finding carcinogen
    Nostrum Laboratories has recalled one lot of its metformin tablets after finding levels of nitrosamine above the FDA's accepted limit.

  4. Fresenius Kabi recalls NSAID due to presence of particulate matter
    Fresenius Kabi has recalled one lot of its drug ketorolac after finding particulate matter in some of the vials.

  5. Boston Scientific recalls aortic valve device
    Boston Scientific has recalled its LOTUS edge aortic valve system, saying the delivery system for the device is too complex. There's no safety issue for patients who currently have the device.

  6. Penumbra recalls JET 7 Xtra Flex catheter
    Penumbra has recalled its JET 7 Xtra Flex after finding the tip of the device is susceptible to damage during use. The FDA has received more than 200 adverse event reports related to the device, including deaths and serious injuries.

  7. Boston Scientific recalls cardiac device
    Boston Scientific has recalled its implantable defibrillator device after finding an increased risk of the device fracturing during use. The FDA has received 26 reports of serious injuries related to the device.

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FDA to streamline process to approve vaccines updated for protection against virus variants

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