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U.S. Department of Health and Human Services

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Recall -- Firm Notice 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Recall of Children's BENADRYL® Allergy FASTMELT® Tablets and Junior Strength MOTRIN® Caplets

 

Company Contact:
Consumer Care Center at 1-888-222-6036

 

November 15, 2010 - In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. has initiated a voluntary recall of all product lots of Children's BENADRYL® Allergy FASTMELT® Tablets, in cherry and grape flavors, that were distributed in the United States, Belize, Barbados, Canada, Puerto Rico, St. Martin, and St. Thomas and all product lots of Junior Strength MOTRIN® Caplets, 24 count, that were distributed in the United States.

This is a wholesale and retail level recall. No action is required by consumers or healthcare providers and consumers can continue to use the product. The recall was initiated after a review, conducted as part of McNeil's Comprehensive Action Plan, revealed insufficiencies in the development of the manufacturing process. There is no indication that the recalled products do not meet quality standards, and this recall is not being undertaken on the basis of adverse events.

Consumers with questions should call our Consumer Care Center at 1-888-222-6036 (available Monday-Friday from 8 a.m. – 8 p.m. ET and Saturday – Sunday, 9 a.m. – 5 p.m. Eastern Time.)

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Photo: Product Labels

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