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  • pv223 replied to the topic FDA on Recalled Items in the forum Regulatory Basics for Medical Devices 6 years, 8 months ago

    Back on September 9, 2018 the FDA recalled a lot of Montelukast Sodium 10 mg tablets, the generic for Singulair 10mg. The reason behind this recall was a product/label mix-up which may result in some tablets of Losartan Potassium, or Cozaar, to be mixed into the bunch. This is a huge issue because Losartan is a medication that is used to treat high blood pressure in while Montelukast is a medication used to help with allergies and asthma. If someone who takes Montelukast accidentally took Losartan, they could have experienced symptoms like dizziness. A more serious risk that could occur from this mix-up would be fetal toxicity, which could result in death if taken by a pregnant woman. While it is a good thing that the FDA issued this voluntary recall, Camber Pharmaceuticals are to blame for not taking more care in making sure the medication they were distributing was not prepared correctly.

    Source: https://www.fda.gov/Safety/Recalls/ucm619825.htm