Safety

MedWatch: The FDA Safety Information and Adverse Event Reporting Program

 

What's New 

  • BLUEFUSION Capsules by Ata Int: Recall - Due to Presence of Undeclared Sildenafil, Tadalafil, Desmethyl Carbodenafil, Dithiodesmethyl Carbodenafil, Scutellarin and Daidzein intended for Consumer, Pharmacy, Urology. [03/22/2019]

  • Levoleucovorin Injection by Mylan Institutional: Recall - Due to the Presence of Particulate Matter intended for Health Professional, Risk Manager, Pharmacy. [03/19/2019]

  • Transseptal Needle by Cook Medical: Class I Recall - Due to Risk of Detached Plastic Fragments intended for Health Professional, Risk Manager. [03/18/2019]

  • 8.4% Sodium Bicarbonate Injection by Hospira: Recall - Due to the Presence of Particulate Matter intended for Health Professional, Risk Manager, Pharmacy. [03/18/2019]

  • Losartan Potassium Tablets by Legacy Pharmaceutical Packaging (by Camber Pharmaceuticals and by Torrent Pharmaceuticals): Recall - Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid Impurity Found in The Active Pharmaceutical Ingredient intended for Patient, Health Professional, Pharmacy. [03/18/2019]

 

2019 Safety Alerts for Human Medical Products  

March 2019

February 2019

January 2019

 

FDA Approved Safety Information

Page Last Updated: 04/09/2019
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