McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children's Products (April 30, 2010)
These products include Infant and Children's Tylenol, Motrin, Benadryl and Zyrtec.
(It is safe to substitute generic or store brand acetaminophen or ibuprophen, during the recall.)
Update: November 2010
The first children's Tylenol products are returning to drugstore shelves after a long safety recall, and maker Johnson & Johnson now faces the tricky task of persuading parents to buy the pain reliever again.
Bottles of the grape-flavored version of children's Tylenol have begun reappearing in pharmacies across the country half a year after several J&J over-the-counter children's medicines were pulled because of manufacturing problems. The company began shipping one million bottles last month, and other recalled medicines will return through the middle of next year.
The recalls have cost the company hundreds of millions of dollars in lost sales and prompted a shake-up of manufacturing and management at its consumer-goods business. The quality problems included floating metal particles in the medicines and the potential for excessive concentrations of an active ingredient.
To get parents to return to Tylenol, J&J must combat not just the hit to its reputation but also the encroachment of rival brands, which have been taking over shelf space in drugstores and promoting themselves as safe and reliable. Cheaper private-label brands are also gaining amid the tough economy as sales of branded medicines drop. For example, private-label cough and cold remedy sales rose 6% from a year earlier to $2.4 billion during July, August and September, Nielsen Co. said.
J&J must walk a messaging tightrope, marketing experts say, providing reassurance that it has fixed its problems without calling so much attention to them that safety concerns resurface.
"You don't want to always be apologizing, because that cues the wrong response. You want to be cuing the core emotional benefits that Tylenol delivers," said Rex Briggs, chief executive of Marketing Evolution, which has done consulting work for J&J.
J&J declined to comment about its plans.
At least initially, the reintroduction of Tylenol is low key. There are no signs in stores calling attention to the return, for instance. The grape version's red-and-purple packaging appears similar to the box before the recall. It pictures smiling mothers and children and says that mothers have "trusted" the medicine for 50 years.
But Tylenol rivals aren't going to make the products' return easy. Pfizer Inc.'s website for Advil notes that it was "not part of this year's pain reliever recalls" and refers to the children's and infants' versions of the pills as "relief you can trust."
Tylenol Recall (April 2010)
McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling all lots that have not yet expired of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait.
McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use.
The company is conducting a comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before new manufacturing is initiated at the plant where the recalled products were made. Production of these products is not expected to resume until early 2011.
Consumers can contact the company at 1-888-222-6036 and also at www.mcneilproductrecall.com. Parents and caregivers who are not sure about alternative pediatric health treatment options should talk to their doctor or pharmacist and are reminded to never give drug products to infants and children that are not intended for those age groups as this could result in serious harm.
For additional information, including affected NDC numbers, consumers should visit our website www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
McNeil Consumer Healthcare, Division of McNeil-PPC, Inc. markets a broad range of well-known OTC products.