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 »

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 »

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 »

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 »

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