More J&J Quality Problems Revealed with New Recall

Alexis Brekke Pellek PharmTech editorQuality improvements at Johnson & Johnson was the focus of last week’s news about the company. This week, unfortunately, it’s back to recalls and warning letters. Read more »

J&J Plans to Improve Manufacturing Quality

Alexis Brekke Pellek PharmTech editorJohnson & Johnson’s CEO William Weldon told The Wall Street Journal this week that the company will change its manufacturing operations and create a new position responsible for company-wide quality that reports directly to him. The company’s numerous recalls and manufacturing problems during the past year have resulted in a Congressional hearing and harsh words from FDA inspectors—in addition to shaken consumer confidence. Read more »

FDA Needs More Muscle and Money

Erik Greb PharmTech editorThe welter of recent product recalls (and phantom recalls) initially got the US Congress talking about the adequacy of Johnson and Johnson’s (J&J, New Brunswick, NJ) manufacturing and quality-control operations. But lawmakers soon began asking questions about our line of defense against potentially harmful products: the US Food and Drug Administration. Read more »

Lundbeck Voluntarily Recalls Injectable Ibuprofen Used to Treat Premature Infants

Alexis Brekke Pellek PharmTech editorLundbeck (Deerfield, IL) issued a voluntary recall of its anti-inflammatory drug NeoProfen (ibuprofen lysine) Injection last Friday because it contains visible particulates, according to a company press release. The recall will cause a temporary shortage of the drug because the company recalled both lots that are currently available to prescribers. Read more »

Congress Moves Again on Drug Safety and Quality

Patricia Van Arnum PharmTech editor As Congress prepares to go into summer recess and begin the legislative season again after Labor Day, a subject that has been of ongoing concern for the pharmaceutical and fine-chemical industries has resurfaced: drug safety by reforming regulatory oversight for foreign drug-manufacturing facilities and related issues. The bill, the Drug Safety and Accountability Act of 2010, introduced this week by Sen. Michael Bennet (D-CO), raises again the issue on how best to oversee an increasingly global pharmaceutical supply chain. Read more »

J&J and Guilt by Association

Erik Greb PharmTech editorPublicity about substandard or contaminated products usually lights a fire under pharmaceutical companies, which then race to address their compliance problems. But a new US Food and Drug Administration inspection report shows that, despite a stream of product recalls and a Congressional investigation, Johnson & Johnson (J&J, New Brunswick, NJ) has not gotten its house in order yet. And the company’s latest problems conceivably could make things hot for one of its partners. Read more »

A Timeline of J&J/McNeil’s Recent Recall Troubles

Alexis Brekke Pellek PharmTech editorJohnson & Johnson and its McNeil Consumer Healthcare unit have been all over the news lately for all the wrong reasons. Another recall was issued last week, as was news of a class-action lawsuit in the works against the company. The timeline below summarizes the recent events surrounding J&J/McNeil’s recalls and news. Read more »

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 »

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 »

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