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.)

     

Product Description:
Children’s BENADRYL® Allergy FASTMELT® Tablets, Cherry Flavor

Children’s BENADRYL® Allergy FASTMELT® Tablets, Cherry Flavor

NDC Code:
50580-347-18
UPC Code:
300450180186
UPC Code:300450180186
 
     

Product Description:
Children’s BENADRYL® Allergy FASTMELT® Tablets, Grape Flavor

Children’s BENADRYL® Allergy FASTMELT® Tablets, Grape Flavor

NDC Code:
50580-348-18
UPC Code:
300450190185
UPC Code:300450190185
 
     

Product Description:
Junior Strength MOTRIN® CAPLETS, 24 count

Junior Strength MOTRIN® CAPLETS, 24 count
NDC Code:
50580-498-24
UPC Code:
300450498243
UPC Code:300450498243
 
 

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