Monday, May 3, 2010

Childrens Medication Recall Update


J&J recalls children's OTC medicines.

The CBS Evening News (5/1, story 8, Glor) reported, "The FDA...is advising consumers to avoid more than 40 liquid medications for children that are being recalled by the manufacturer because of quality problems. The products include children's and infants' Tylenol, children's and infants' Motrin, as well as children's Zyrtec [cetirizine] and Benadryl [diphenhydramine]."
The Washington Post (5/2, Layton) reported, "A division of Johnson & Johnson is recalling 43 over-the-counter medicines made for infants and children...after federal regulators identified what they called deficiencies at the company's manufacturing facility." McNeil Consumer Healthcare announced "the voluntary recall," which "affects hundreds of thousands of bottles of medicine" that make up "a vast portion of the children's medicine market."
The New York Times (5/2, A21, Singer) reported, "The deficiencies may affect the potency, purity or quality of the products, the agency said." The FDA also "said it was investigating the plant where the products were made to make sure there were no other problems."
The recall includes pediatric formulations of Tylenol, Motrin and Zyrtec, the Wall Street Journal (4/3, Rockoff) reports. A spokeswoman for McNeil indicated that the active ingredient in some products may be at a higher concentration than it should, while inactive ingredients in other products may be at levels the company says are inappropriate.
Bloomberg News (5/1, Hart) reported that McNeil "said the likelihood of any serious reactions is 'remote,' although it urged consumers who have the products not to use them."
The FDA "advised consumers to stop using the medicine as a precaution," the AP (5/2) reported. Consumers should contact "a healthcare professional...a child has recently taken any of the recalled products and is exhibiting unexpected symptoms," and "parents in the interim should consider substitute child medications."
The Chicago Tribune (5/2, Graham, Eldeib), HealthDay (5/1), MedPage Today (5/1, Peck), and WebMD (5/2, DeNoon) also cover the story.
Analysts assess impact of J&J's response on consumer confidence. On the front page of its Business Day section, the New York Times (5/3, B1, Singer) reports that although "Johnson & Johnson is considered a model in the consumer products industry," the company "and its McNeil unit "may have more difficulty wooing customers back because the latest recalls stem from problems at company plants, industry analysts said." In fact, "some consumers said they found the company's initial response flat-footed," as they were "unable to obtain clear information about how to receive a refund on...a company website about the recalled products," and some consumers "complained that they could not get through to customer service representatives at the company's recall hot line."
The Wall Street Journal (5/3, Winslow, Johnson) reports that J&J has been criticized by regulators for how the company handles issues with product quality. Last year, the company received a warning letter from the FDA after widening its recall of Tylenol arthritis-pain caplets to include all lots of the product, as well as other brands.

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