Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response to the particulate or microembolic effects.

This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice.

View Full Details Of The Original MedWatch Notice Here.

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The U.S. Food and Drug Administration today approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, an opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

This is a summary of a Press Release issued by the Food and Drug Administration (FDA). The link below will take you to the original press release containing complete information, including instructions about what to do if you are affected.

View Full Details Of Original FDA Press Release Here.

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September 2014

by FDA on October 16, 2014

in MedWatch

September 2014 Drug Safety Labeling Changes includes 55 products with revisions to Prescribing Information.

This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice.

View Full Details Of The Original MedWatch Notice Here.

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Weld on the drive axle can fail resulting in loss of brake control, posing an injury hazard.

This is a summary of a recall issued by the Consumer Product Safety Commission (CPSC). The link below will take you to the original recall press release containing complete information, including instructions about what to do if you are affected by this recall.

View Full Details Of Original CSPC Recall Notice Here

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Dated: SEP 09, 2014 Mazda North American Operations (Mazda) is recalling certain model year 2008 Mazda Tribute Hybrid vehicles manufactured October 10, 2006, to May 23, 2008. The coolant pump for the hybrid system may f…

This is a summary of a recall issued by the National Highway Transportation Safety Administration (NHTSA). The link below will take you to the original recall press release containing complete information, including instructions about what to do if you are affected by this recall.

View Full Details Of Original NHTSA Recall Notice Here.

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On 2014 Pioneer 700 vehicles, vegetation and debris can accumulate on the middle skid plate, make contact with the exhaust system and ignite.

This is a summary of a recall issued by the Consumer Product Safety Commission (CPSC). The link below will take you to the original recall press release containing complete information, including instructions about what to do if you are affected by this recall.

View Full Details Of Original CSPC Recall Notice Here.

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The nut securing the television to the main arm assembly can loosen causing television to become detached from the arm assembly, posing an impact hazard.

This is a summary of a recall issued by the Consumer Product Safety Commission (CPSC). The link below will take you to the original recall press release containing complete information, including instructions about what to do if you are affected by this recall.

View Full Details Of Original CSPC Recall Notice Here

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FDA approves Ofev to treat idiopathic pulmonary fibrosis

October 15, 2014

The U.S. Food and Drug Administration today approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF). This is a summary of a Press Release issued by the Food and Drug Administration (FDA). The link below will take you to the original press release containing complete information, including instructions about what to do if [...]

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FDA approves Esbriet to treat idiopathic pulmonary fibrosis

October 15, 2014

The U.S. Food and Drug Administration today approved Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF). This is a summary of a Press Release issued by the Food and Drug Administration (FDA). The link below will take you to the original press release containing complete information, including instructions about what to do if [...]

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LifeCare Flexible Intravenous Solutions by Hospira, Inc.: Recall – Potential for Leakage

October 15, 2014

A puncture in the primary container may be difficult to detect and lead to contamination, compromised sterility, and other adverse events. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The [...]

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