The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses to standard treatment for CLL. Imbruvica received a breakthrough therapy designation for this use.

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.

{ 0 comments }

Physicians may make decisions based on incorrect values which could lead to permanent, irreversible impairment or life-threatening changes in patients.

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.

{ 0 comments }

Physicians may make decisions based on incorrect values which could lead to permanent, irreversible impairment or life-threatening changes in patients.

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.

{ 0 comments }

The U.S. Food and Drug Administration and the government of Mexico’s National Service for Agro-Alimentary Public Health, Safety and Quality (SENASICA) and Federal Commission for the Protection from Sanitary Risks (COFEPRIS) signed a statement of intent forming a partnership to promote the safety of fresh and minimally processed agricultural products.

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.

{ 0 comments }

The U.S. Food and Drug Administration is alerting health care professionals and consumers of a voluntary recall of all non-expired drug products produced for sterile use by Unique Pharmaceuticals Ltd., of Temple, Texas.

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.

{ 0 comments }

The U.S. Food and Drug Administration today approved Zydelig (idelalisib) to treat patients with three types of blood cancers.

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.

{ 0 comments }

Failure to receive the proper dose of oxcarbazepine could increase the chances of patients having a seizure and inadvertent consumption of ibuprofen may cause adverse reactions.

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.

{ 0 comments }

FORD ( 14V336000 )

July 19, 2014

Dated: JUN 17, 2014 Dual-Tech, Inc. (Dual-Tech) is recalling certain model year 2009-2014 Ford F-550 Super Duty trucks modified by Dual-Tech, equipped with certain Muncie Power Products PTO Assemblies. In the affected v… This is a summary of a recall issued by the National Highway Transportation Safety Administration (NHTSA). The link below will take you [...]

Read More Details →

BMW ( 14V428000 )

July 19, 2014

Dated: JUL 15, 2014 BMW of North America, LLC (BMW) is recalling certain model year 2000 323i sedans, coupes, convertibles, and Sports Wagons; 2000 328i sedans and coupes; 2001-2005 325i sedans, coupes, convertibles, and… This is a summary of a recall issued by the National Highway Transportation Safety Administration (NHTSA). The link below will take [...]

Read More Details →

Sterile Drug Products by Downing Labs (aka NuVision Pharmacy): Drug Alert – Lack of Sterility Assurance

July 18, 2014

Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death 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 [...]

Read More Details →