McNeil Consumer Healthcare is voluntarily recalling certain lots of Tylenol 8-Hour, Tylenol Arthritis Pain, Tylenol upper-respiratory products, Benadryl, Sudafed PE and Sinutab at the wholesale level.


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McNeil recalls some OTC medicines at wholesale

January 17th, 2011

FORT WASHINGTON, Pa. – McNeil Consumer Healthcare is voluntarily recalling certain lots of Tylenol 8-Hour, Tylenol Arthritis Pain, Tylenol upper-respiratory products, Benadryl, Sudafed PE and Sinutab at the wholesale level.

The McNeil-PPC Inc. division, which is part of Johnson & Johnson, said Friday that the affected products were distributed in the United States, the Caribbean and Brazil and were manufactured at the McNeil plant in Fort Washington, Pa., before April 2010, when production at the facility was suspended.

According to McNeil, the recall of the over-the-counter medicines is a precautionary measure after an extensive review of past production records found instances in which equipment cleaning procedures were insufficient or cleaning wasn't adequately documented. The company stated, "It is very unlikely that this impacted the quality of these products."

Affected products include various counts and/or flavors of Tylenol Cold Head Congestion and Tylenol Cold Head Congestion Severe caplets, Tylenol Sinus Congestion & Pain Severe caplets, Tylenol Cold Multi-Symptom and Tylenol Cold Multi-Symptom Severe caplets, Tylenol Allergy Multi-Symptom caplets, Tylenol Arthritis Pain Geltabs, Tylenol Arthritis Pain caplets, Tylenol 8-Hour caplets, Benadryl Allergy & Cold Kapgels, Benadryl Allergy Plus Sinus Headache Kapgels, Benadryl Severe Allergy Plus Sinus Headache caplets, Sudafed PE Day & Night Cold coated caplets, Sudafed PE Cold & Cough coated caplets, Sudafed PE Non-Drying Sinus coated caplets, Sudafed PE Severe Cold coated caplets, Sudafed PE Nighttime Cold coated caplets, Sudafed PE Sinus Headache coated caplets, Sudafed PE Triple Action coated caplets and Sinutab Sinus coated caplets.

In addition, McNeil said it's voluntary recalling certain lots of Rolaids Multi-Symptom Berry Tablets distributed in the United States to update the labeling. The company initiated the recall of the antacid product after determining that its labeling doesn't have the language "Does not meet USP," as required by regulation.

Both of the recalls are being initiated at the wholesale level, McNeil noted, adding that no action is required by consumers or health care providers and consumers can continue to use the product. The actions being taken aren't the result of adverse events, according to the company.

The wholesale recall is the latest of a spate of product recalls by McNeil that began a year ago. Last month, McNeil said it was pulling back all lots of Rolaids soft chewables, a move that marked the company's fourth recall announcement since mid-November.

In announcing the wholesale recalls, McNeil said it identified the inadequacies as part of a "thorough, proactive product quality and process assessment of all McNeil produced products." The company noted on Friday that it has been implementing a comprehensive action plan at its U.S. manufacturing facilities to improve the quality systems at those sites.

As part of the action plan, which was submitted to the Food and Drug Administration in July 2010, McNeil investigated its historical records as far back as 2007 for products sold in the United States and produced in its internal manufacturing network. And for each product, the company examined whether the right processes were identified and followed, and it evaluated whether quality standards were met. McNeil said Friday the assessment has now been completed, representing a significant milestone in the plan.

The assessment identified a number of areas for improvement, which are being addressed, according to McNeil. For example, the company flagged instances where equipment cleaning procedures were insufficient or cleaning wasn't adequately documented. Those issues occurred at the Fort Washington plant prior to April 2010, when production at the facility was suspended.

"Steps we have taken under the comprehensive action plan constitute an uncompromising and systematic effort to review quality and manufacturing practices at McNeil," Johnson & Johnson chairman and chief executive officer Bill Weldon said in a statement. "They help us assure that moving forward, any of our products in the marketplace live up to the trusted standards and expectations that consumers have for all products coming from a Johnson & Johnson company, anywhere in the world."

McNeil added that as a continuing part of this effort, the company is conducting assessments at other sites that manufacture its products.

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