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FDA Medwatch Alert: Sterile Drug Products by Bella Pharmaceuticals: Recall - Lack of Sterility Assurance
Posted 20 Aug 2017 by Drugs.com
[Posted 08/18/2017] ISSUE: Bella Pharmaceuticals is voluntarily recalling all lots of unexpired sterile drug products due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To date, Bella Pharmaceuticals has not received any reports of adverse events. BACKGROUND: The affected products include all lots distributed April 17, 2017, to August 10, 2017, remaining within expiry, and they would be packaged in a syringe, vial or eye dropper. For a list of products affected by this recall see the Firm Press Release. RECOMMENDATION: Bella Pharmaceuticals is notifying its customers by email and phone, and is arranging for the return of all recalled products. Anyone with product subject to the recall ... Read more
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Posted 10 Oct 2014 by Drugs.com
THURSDAY, Oct. 9, 2014 – Although food allergies have garnered a lot of attention lately, a new study reports that medications are actually the biggest cause of sudden deaths related to allergy. Over a little more than a decade, nearly 60 percent of the allergy-related deaths were caused by medications, while less than 7 percent were caused by food allergies, the study found. "Medications can be dangerous," said study researcher Dr. Elina Jerschow, director of the Drug Allergy Center at Montefiore Medical Center and assistant professor of medicine at Albert Einstein College of Medicine, in New York City. While research from other countries has reported medications as a major culprit in anaphylaxis-related deaths, Jerschow said, the problem has been less defined in the United States. One reason is that there is no national registry for anaphylaxis deaths, she said. The study was ... Read more
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