Odorous Taints Linked to Treated Wood Pallets

It is amazing what the human nose knows.  Well, those who originally detected a musty, moldy odor in pharmaceutical and healthcare products didn’t know where it came from.  But the odorous taints that resulted in product recalls were found to come from tribromoanisole (TBA) and trichloroanisole (TCA), and have been linked to treated wooden pallets from sources outside the US, the Parenteral Drug Association (PDA) reported in a September PharmTech article, which summarizes the findings of the recent PDA Technical Report No. 55 on detecting and mitigating taints and odors from TBA and TCA. Read more »

A Taste Of Someone Else’s Medicine

Stephanie Sutton Pharm Tech EuropeMistakes happen. In the pharma industry, these mistakes can lead to product recalls. Perhaps the medication is not the correct strength or maybe it became contaminated with metal fragments…

…and sometimes, entirely the wrong drug is found in the packet. In a case that has had UK media reports aflame, a prescription only antipsychotic drug was found in certain packets of a common pain medication that was manufactured by a completely different company. Is it a repackaging mistake? Or are more sinister intentions at work? Either way, it’s clear there are could be a few security holes in pharma’s distribution chains. Read more »

Consent Decree (Finally) for J&J

Erik Greb PharmTech editorBeginning in September 2009, I watched with increasing surprise as Johnson & Johnson (J&J) recalled more and more of its products. As the recalls kept coming, my surprise turned to amazement that some of the company’s facilities (particularly the one at Fort Washington, Pennsylvania) could have been maintained and run in such an apparently haphazard way. As time went on, my amazement ebbed, and the continuing stream of recalls elicited little more than a shrug. Read more »

PharmTech Poll Shows Readers Favor Expanding FDA’s Recall Power

Alexis Brekke Pellek PharmTech editorA recent poll on PharmTech.com asked readers whether FDA should have the authority to issue recalls for pharmaceutical products, and 86% of readers were in favor of allowing the agency to do so. Read more »

Should FDA Have Drug-Recall Authority?

Alexis Brekke Pellek PharmTech editorOn Jan. 4, President Obama signed the FDA Food Safety Modernization Act. The bill expands FDA’s oversight of the food industry and grants the agency, among other things, the authority to issue mandatory food recalls (see back story).

PharmTech is asking readers in our current poll whether FDA should have the same power over pharmaceutical recalls. Right now, nearly 90% of respondents have said  “Yes.” Read more »

FDA to Gain Food Recall Authority, Drugs Could be Next

Alexis Brekke Pellek PharmTech editorFDA is close to receiving the authority to mandate recalls of food under a new food-safety bill. Efforts are underway in the House to grant the agency this power for pharmaceuticals as well. Read more »

J&J’s Fort Washington Plant Cited for Quality Problems; Two Vice-Chairmen Appointed

Alexis Brekke Pellek PharmTech editorMcNeil Consumer Healthcare, a business unit of Johnson & Johnson (New Brunswick, NJ), failed to ensure the quality of over-the-counter consumer products, according to the Form 483 report released by the US Food and Drug Administration on Wednesday. Read more »

Hearing Reviews J&J “Phantom Recall,” Discusses Granting FDA Recall Authority

Alexis Brekke Pellek PharmTech editorJohnson & Johnson CEO William Weldon admitted last week that the company “should have handled things differently” in regard to its “phantom recall” of Motrin. The second hearing of The House Committee on Oversight and Government Reform focused on the “phantom recall,” in which outside contractors were hired to pose as customers and buy two lots of 8-caplet Motrin vials to remove them from store shelves. Read more »

J&J CEO, FDA to Testify at Second Congressional Hearing Today

Alexis Brekke Pellek PharmTech editorJohnson & Johnson Chairman and CEO William Weldon is scheduled to testify at today’s hearing held by the The House Committee on Oversight and Government Reform. Weldon is expected to answer questions about J&J/McNeil Consumer Healthcare’s April 30, 2010, recall of more than 135 million bottles of infants’ and children’s medication. Read more »

J&J Orthopaedics Unit Recalls Two Hip-Replacement Systems

Alexis Brekke Pellek PharmTech editorDePuy Orthopaedics, a business unit of J&J that makes joint replacements, announced a voluntary recall last week of two hip-replacement products, the ASR XL acetabular system and DePuy ASR hip resurfacing system. Read more »

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