6 recent drug, device recalls

Medical device and drug recalls, whether voluntary or mandated by the FDA, ensure patient safety. Here are six reported to the FDA since Aug. 24:

  1. Sun Pharmaceuticals recalls metformin after finding NDMA
    Sun Pharmaceuticals has recalled one lot of its metformin pills after finding levels of N-Nitrosodimethylamine, or NDMA, a carcinogen, above the acceptable daily intake limit.

  2. Acella recalls thyroid drug for subpotency
    Acella Pharmaceuticals has recalled two lots of its thyroid drugs due to subpotency. 

  3. Becton Dickinson recalls Alaris infusion pump system for several hardware issues
    Becton Dickinson has recalled its Alaris infusion pump system for a series of hardware issues that the FDA classified as Class I, the most serious type of recall, meaning use of the device could result in serious injury or death.

  4. RLC labs recalls thyroid drug due to subpotency
    RLC Labs, a drugmaker that focuses on drugs to treat hypothyroidism, recalled 483 lots of its Nature-Throid and WP Thyroid drugs after an FDA review found they were subpotent.

  5. Mylan recalls 2 drugs after label mix-up
    Mylan has recalled four lots of amiodarone HCl injection, which treats heart rhythm issues, and tranexamic acid injection, which promotes blood-clotting, after learning of a carton label mix-up.

  6. Smiths Medical recalls syringe pumps due to risk of medication delivery error
    Smiths Medical has recalled its Medfusion syringe pumps after finding a software issue may lead to over- or underdelivery of medication.

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