Children's Tylenol, Motrin, Zyrtec and Benedryl Products RecalledMay 3, 2010 | Parker Waichman LLP
Children’s versions of Tylenol, Tylenol Plus, Motrin, Zyrtec and Benadryl were recalled over the weekend by McNeil Consumer Healthcare, a division of Johnson & Johnson. According to the recall notice, the children’s medications were recalled because of manufacturing deficiencies which may affect quality, purity or potency.
The recall includes more than 40 varieties of Tylenol Infant Drops, Children’s Tylenol Suspensions, Children’s Tylenol Plus Suspensions, Motrin Infant Drops, Children’s Motrin Suspensions, Children’s Zyrtec Liquid in Bottles, and Children’s Benadryl Allergy Liquid in Bottles. A complete list of recalled products is available here.
In addition to the U.S., the recall is taking place in 11 other countries. These include: Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait.
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, consumers who have purchased these recalled products are advised to discontinue use.
According to a press release from McNeil, 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.
The U.S. Food & Drug Administration (FDA) is recommending that consumers use other products on the market, including generic versions of the recalled products, which are intended for use in infants and children and are not affected by the recall. The agency said it does not anticipate that there will be a shortage of alternative products.
All of the recalled drugs were made at a factory in Fort Washington, PA. The FDA said it was reviewing procedures at McNeil, which appears to be the sole source of the problems. For its part, McNeil said it 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.
According to McNeil, consumer complaints about some of the recalled medications prompted an internal review at the Pennsylvania facility. That in turn led to the recall.
This is not the first time McNeil has pulled over-the-counter products from store shelves because of consume complaints. Last November, the company recalled 5 lots of Tylenol Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP following consumer reports of a musty odor, which was associated with nausea, stomach pain, vomiting and diarrhea.
That recall was expanded in December to include all lots of the Tylenol Arthritis Pain Caplets. Then in January, the list of recalled drugs was expanded yet again to include various lot of Tylenol, Rolaids, Benedryl and St. Joseph’s Aspirin. In total, the expanded recall included about 50 million bottles of the medications.