McNeil Consumer Healthcare has recalled all unexpired lots of the following over-the-counter (OTC) medications:
- CONCENTRATED TYLENOL® INFANTS’ DROPS – various sizes and flavors
- CHILDREN’S TYLENOL® SUSPENSION – various sizes and flavors
- CHILDREN’S TYLENOL® DYE-FREE SUSPENSION, 4 oz. – Cherry flavor
- CHILDREN’S TYLENOL® PLUS SUSPENSION, 4 oz. – various varieties (including dye-free) and flavors
- CONCENTRATED MOTRIN® INFANTS’ DROPS – various sizes; Berry and dye-free Berry flavors
- CHILDREN’S MOTRIN® SUSPENSION – various sizes and flavors
- CHILDREN’S ZYRTEC® liquids – various sizes, varieties (including dye-free and sugar- and dye-free) flavors
- CHILDREN'S BENADRYL® ALLERGY, 4 oz. – Bubble gum flavored liquid
Two of the recalled items – Concentrated Tylenol® Infants' Drops (0.5 oz. Grape Flavor) and Concentrated Motrin® Infants' Drops (0.5 oz. Berry Flavor) – also are included in JOHNSON'S® Baby Relief Kit. McNeil Consumer Healthcare is a Johnson & Johnson company.
The recalled OTC products were sold in the United States, Canada, the Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait.
FDA has supplemented the McNeil recall notice with a separate news release containing guidance for consumers, and providing the following explanation for this recall:
"McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. 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 specified; others 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, FDA advises consumers who have purchased these recalled products to discontinue use."
Today's recall represents the latest in a series of safety and quality recalls that have bedeviled McNeil's manufacturing operations since an FDA inspection of the company's Puerto Rico production facility – conducted between October 22, 2009 and January 8, 2010 – uncovered significant problems at that location.
According to a report on MarketWatch, the products covered by today's recall were manufactured in a Pennsylvania production facility, and not in the Puerto Rico plant. Additional details on this, and earlier, McNeil product recalls can be accessed on a special McNeil website at www.mcneilproductrecall.com.
Consumers or health professionals wishing to report an adverse reaction to one of the recalled products can do so using FDA's MedWatch program.
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