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Category Archives: Recalls
Azithromycin (Zithromax or Zmax): Drug Safety Communication – Risk of Potentially Fatal Heart Rhythms
On March 12, 2013 the FDA posted a warning to the public that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. Patients at … Continue reading
Affymax and Takeda Announce a Nationwide Voluntary Recall of All Lots of OMONTYS® (peginesatide) Injection
The FDA issued a safety alert on February 23, 2013 alerting health care professionals and patiens of a voluntary nationwide recall of all lots of OMONTYS® (peginesatide) Injections by Affymax, Inc. and Takeda Pharmaceutical Company Limited, According to the companies, … Continue reading
Posted in Recalls
Tagged anaphylaxis, FDA, FDA MedWatch Program, FDA recall, Omontys
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Medical Device Class I Recall: Lumenis Limited, Lumenis VersaCut Tissue Morcellator
According to the FDA on February 25, 2013, Lumenis Limited is recalling certain models of VersaCut Morcellator devices to correct its labeling. These devices break up and remove dissected tissue during surgical procedures when access to the surgical site is … Continue reading
Posted in Recalls, Safety Tips
Tagged class I recall, FDA, FDA recall, medical device recall
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Class I Recall: DePuy Orthopaedics, Inc recalls LPS Diaphyseal Sleeve
According to the FDA on January 4, 2013, DePuy issued an Urgent Medical Device Recall informing hospitals and surgeons of the problem and to immediately stop distributing or using the recalled lots. The LPS Diaphyseal Sleeve is intended for use … Continue reading
Posted in Case Results, Recalls
Tagged FDA, medical device recall, personal injury, recalls
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FDA Issues Statement on Fungal Meningitis Outbreak
As of October 5, the FDA has been working closely with the CDC and state partners to investigate an outbreak of meningitis among patients who had received an epidural steroid injection. Investigation into the exact source of the outbreak is … Continue reading
Posted in Recalls
Tagged CDC, FDA, fungal meningitis, Massachusetts, medication, New England, steroids
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