Johnson and Johnson Recalls Children's Benadryl Tablets and Junior Strength Motrin

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Johnson & Johnson has issued a recall of about 4 million packages of Children’s Benadryl allergy tablets and 800,000 bottles of Junior Strength Motrin caplets citing insufficiencies in the development of the manufacturing process. A company spokesperson noted that the recall “is not being undertaken on the basis of adverse events” or safety issues.

Consumers Do Not Need to Take Action

The McNeil Consumer Healthcare unit of J & J is recalling all product lots of Children’s Benadryl allergy Fastmelt tablets in cherry and grape flavors that were distributed in the US, Canada, Puerto Rico, Belize, Barbados, St. Martin, and St. Thomas. The following NDC Codes/UPC Codes are involved:

• Cherry Flavor FastMelt Tablets: NDC Code 50580-347-18, UPC Code 300450180186
• Grape Flavor FastMelt Tablets: NDC Code 50580-348-18, UPC Code 300450190185

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The 24-count bottles of Junior Strength Motrin caplets were distributed in the US only. NDC Code is 50580-498-24 and UPC Code is 300450498243.

The products were made at J&J’s Fort Washington, Pennsylvania plant before it was temporarily closed. The company discovered the inadequate manufacturing process as part of a review it is conducting in the wake of recent issues. The plant is currently undergoing a upgrade and production of over-the-counter medicines has been shifted to other facilities.

J&J’s McNeil unit withdrew more than 40 types of children’s over-the-counter liquid medicines in April 2010, including the liquid version of Children’s Benadryl. The U.S. House Oversight and Government Reform Committee has been investigating the recall and a separate incident involving adult Motrin tablets.

The company states that it is a wholesale and retail level recall and that no action is required by consumers or healthcare providers. “Consumers can continue to use the product, they don’t have to take any action,” company spokeswoman Bonnie Jacobs said. Questions about the recall can be directed to the J&J Consumer Care Center at 1-888-222-6036.

For more on Johnson & Johnson's recent recalls, please read:
FDA Expands Investigation into J&J McNeil Consumer Healthcare
Tylenol Recall - Alternatives for OTC Cough and Cold Medicines
McNeil Consumer Healthcare Recalls Tylenol Arthritis Pain Caplets
Tylenol Recall 2010 and Past Troubles

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