J&J CEO Invited to Second Congressional Hearing

Alexis Brekke Pellek PharmTech editorThe House Committee on Oversight and Government Reform asked Johnson & Johnson CEO Bill Weldon to testify at a second hearing to explore the company’s recent massive recalls of over-the-counter medication, according to reports this week (see Reuters and Bloomberg). Weldon was unable to attend the committee’s May 27 hearing because he was recovering from back surgery at the time. Read more »

Five More Lots Added to January 2010 Tylenol and Benadryl Recall

Alexis Brekke Pellek PharmTech editorMcNeil Consumer Healthcare/Johnson & Johnson is expanding its Jan. 15, 2010, recall to include four lots of Benadryl and one lot of Tylenol, the company announced on Tuesday. The company said these products were “inadvertently omitted from the initial recall action,” which took effect because of consumer reports of a moldy, musty odor from the medication. As in previous recalls, McNeil said that the risk of serious adverse events is remote. Read more »

Heavy Metals Contamination a Problem for McDonalds, Pharma

Alexis Brekke Pellek PharmTech editorLast week’s McDonalds glassware recall is another example of the problem of heavy metals appearing in consumer products. The fast-food giant, in cooperation with the Consumer Product Safety Commission (CPSC), recalled its promotional Shrek glassware because of the elevated level of cadmium found in the glasses. Read more »

More Trouble for J&J: Blacksmith Brands’ PediaCare Recall and J&J’s “Phantom Recall”

Alexis Brekke Pellek PharmTech editorYesterday, US House Oversight and Government Reform Committee Chairman Edolphus Towns sent a letter to Blacksmith Brands (Tarrytown, NY), a provider of over-the-counter drug and healthcare products, questioning the company’s chairman and CEO about the circumstances of its May 28 voluntary recall of four types of pediatric medications. Read more »

Tylenol Hearing to Take Place Today

Alexis Brekke Pellek PharmTech editorThe House Committee on Oversight and Government Reform will hold a hearing this morning at 10 am to investigate the recent recall of more than 40 of McNeil Healthcare’s infants’ and children’s medications. See the link on the committee’s website to connect to the live webcast. Read more »

Some Recalled Infants’ Tylenol Had Too Much Acetaminophen

Alexis Brekke Pellek PharmTech editorThe Wall Street Journal reported yesterday that some of McNeil Consumer Healthcare’s recalled infants’ Tylenol contained as much as 24% more acetaminophen than it should have, according to a letter the company sent to physicians and poison-control personnel. McNeil’s letter stated that the samples containing the 24% increase did not reach the public, but that the company could not be sure “all the individual bottles were within specification or that 24% would have been the maximum,” according to WSJ. Read more »

Water without Side Effects

Erik Greb PharmTech editorWe take for granted that drinking tap water is not going to alter our mood and that eating salmon is not going to throw our hormones out of balance. But trace amounts of pharmaceuticals have been found in drinking water and aquatic life, raising questions about how these chemicals could affect human health. Local and federal governments began to address the issue this year, and a new project by the Environmental Protection Agency (EPA) could be the basis for future solutions. Read more »

Genzyme’s Next Challenge

Erik Greb PharmTech editorLast week, Genzyme’s (Cambridge, MA) Allston Landing, Massachusetts, plant resumed production of Cerezyme, the company’s treatment for Gaucher’s disease. Genzyme presumably found and eliminated the source of contamination that had been reported weeks earlier. You’d think that after putting out this latest fire at the troubled plant, the company would be justified in heaving a sigh of relief. Read more »

Genzyme’s Friday the 13th

Erik Greb PharmTech editorFriday the 13th was an unlucky day for Genzyme (Cambridge, MA). On that day, the company and the US Food and Drug Administration alerted healthcare providers that stainless steel fragments, nonlatex rubber, and fiberlike material had been found in products filled at Genzyme’s Allston Landing manufacturing facility. The enzyme-replacement products Cerezyme, Fabrazyme, Myozyme, Aldurazyme, and Thyrogen were affected. FDA advised that visual inspection and filtration of the products should reduce the risk of administering contaminated medicines to patients. Read more »

When Slumbering Giants Wake

Erik Greb PharmTech editorThe US Food and Drug Administration has taken a lot of heat in recent years. Events such as the heparin scandal and the recall of Actavis’s (Morristown, NJ) Digitek product have led critics to call the agency a lax and ineffectual protector of the public health. These comments, which I think are partly justified, finally seem to have spurred FDA into action. Several initiatives seem to show an agency that wants to regain its credibility and shield us from dangerous medications. Read more »

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