Last Updated: Friday, January 14, 2011 Johnson & Johnson on Friday announced another voluntary recall, this time involving certain lots of Tylenol, Benadryl and other products.
The company has recently issued a number of recalls. The latest, announced by its McNeil Consumer Healthcare division, involves products made before April 2010, at its facility in Fort Washington, Penn., which has been at the centre of the company's problems.Johnson & Johnson Friday announced another voluntary recall, this time involving certain lots of Tylenol, Benadryl and other products. (Paul Sakuma/Associated Press)
Johnson & Johnson said the recall was a precautionary measure after a review of production records "found instances where equipment cleaning procedures were insufficient or that cleaning was not adequately documented."
It said it was "very unlikely" product quality was affected.
The latest recall followed by one day the announcement of a lawsuit against the firm and two subsidiaries by Oregon Attorney General John Kroger, claiming consumers were exposed to defective supplies of Motrin by a delay in public disclosure of a recall.
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Kroger said Wednesday the health-care products company tried to quietly remove Motrin from store shelves in a "phantom recall" without telling consumers. The action has been the subject of a congressional investigation.
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Related: May 2010; Tylenol recall: Serious side effects investigated
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With files from The Associated Press
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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.
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Recall -- Firm Press Release
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McNeil Consumer Healthcare Initiates Voluntary Recall Of Certain Over-The-Counter (OTC) Products
Contact:Consumer:888-222-6036Media:Bonnie Jacobs215-273-8994 (Office)856-912-9965 (Mobile)Marc Boston215-273-7649 (Office)215-429-7034 (Mobile)
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McNeil Consumer Healthcare Initiates Voluntary Recall Of Certain Over-The-Counter (OTC) Products
Contact:Consumer:888-222-6036Media:Bonnie Jacobs215-273-8994 (Office)856-912-9965 (Mobile)Marc Boston215-273-7649 (Office)215-429-7034 (Mobile)
FOR IMMEDIATE RELEASE -
January 14, 2011 - In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. is voluntarily recalling, at the wholesale level, certain lots of TYLENOL® 8 Hour, TYLENOL® Arthritis Pain, and TYLENOL® upper respiratory products, and certain lots of BENADRYL®, SUDAFED PE®, and SINUTAB® products distributed in the United States, the Caribbean, and Brazil.
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These products were manufactured at the McNeil plant in Fort Washington, PA prior to April 2010, when production at the facility was suspended.
The company is initiating the recall as a precautionary measure after an extensive review of past production records found instances where equipment cleaning procedures were insufficient or that cleaning was not adequately documented. It is very unlikely that this impacted the quality of these products.
McNeil Consumer Healthcare is also initiating a voluntary recall of certain product lots of ROLAIDS® Multi-Symptom Berry Tablets distributed in the United States, in order to update the labeling. The company initiated the recall after determining that the product labeling does not include the language “Does not meet USP” as required by regulation.
Both of these recalls are being initiated at the wholesale level. No action is required by consumers or healthcare providers and consumers can continue to use the product. These actions are not being undertaken on the basis of adverse events.
McNeil identified the inadequacies as part of a thorough, proactive product quality and process assessment of all McNeil produced products. As previously announced, McNeil has been implementing a Comprehensive Action Plan at its U.S. manufacturing facilities to improve the quality systems at those sites. This product assessment is a key milestone in the implementation of that plan, and the actions being undertaken as a result of the assessment are part of McNeil’s ongoing commitment to ensure that all its products meet the high quality standards that consumers expect.
Consumers can access full product details and other information about the recall on the http://www.mcneilproductrecall.com/9 website or by calling 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).
Any adverse reactions may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Online: http://www.fda.gov/MedWatch/report.htm10
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm11. Mail to address on the pre-addressed form.
Fax: 1-800-FDA-0178
Fax: 1-800-FDA-0178
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