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Johnson & Johnson Unit Recalls OTC Children’s Meds

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More than 40 over-the-counter children’s medications are being recalled by McNeil Consumer Healthcare, a division of Johnson & Johnson because of manufacturing deficiencies which may affect quality, purity or potency.

According to the recall notice, some of the children’s drugs 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.

The recall includes 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.

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. The FDA said it was reviewing procedures at McNeil, which appears to be the sole source of the problems.

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.

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