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Industry News & Alerts

Below is a listing of the latest industry news items and alerts ranging Compliance Updates to FDA Alerts. Our goal is to provide you with timely and relevant information. Visit the Industry News & Alerts Archive to view past items by date.

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The FDA warns that Lamictal can cause aseptic meningitis.

Miracle Mineral Solution (MMS): Product as consumed produces a potent bleach

21 lots of over-the-counter medicines sold in US, Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidad & Tobago, and Jamaica are recalled.

Serious side effects reported when used to treat or prevent night time leg cramps

The U.S. Food and Drug Administration approved the first generic version of Effexor XR capsules (venlafaxine hydrochloride) to treat major depressive disorder.

P&G Voluntarily Recalls 4 Hour Decongestant Nasal Spray in the United States

FDA Drug Safety Communication: Ongoing safety review of Benicar and cardiovascular events

Blacksmith Brands Announces Nationwide Voluntary Recall Of Four PediaCare Children's Products

Completed safety review of Xenical/Alli (orlistat) and severe liver injury.

Goal is to expand online distribution of Agency’s consumer health information.

The FDA and the NIH launched a new Web site that, when fully developed, will provide a mechanism for the reporting of pre- and post-market safety data to the federal government.

Ortho-McNeil-Janssen and FDA notified healthcare professionals of changes to the Warnings section of the prescribing information for tramadol.

Proton Pump Inhibitors Class Labeling Change including Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, Aciphex, Vimovo, Prilosec OTC, Zegerid OTC, and Prevacid 24HR

Change to Dexilant is part of FDA effort to prevent medication errors.

McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children’s Products

The FDA provides answers to questions about a new approved formulation of the controlled-release drug OxyContin.

The FDA approved a new formulation of the controlled-release drug OxyContin designed to help discourage abuse.

FDA warned company about making medical claims for bee-derived products.

A listing of recent new and generic drugs approved by the FDA.

Maalox product maker agrees to name change to avoid confusion.

FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain. Approval is part of Agency’s unapproved drugs initiative.

Alli 60 mg capsules (120 count refill kit): Counterfeit Product
 

Tylenol Arthritis Pain Caplet, 100 count bottles: Recall of all lots
 

McNeil Consumer Healthcare Announces Voluntary Recall of Certain Over-The-Counter (OTC) Products in the Americas, UAE, and Fiji

 

Industry News & Alerts Archive

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