McNeil Recalls Certain Tylenol, Benadryl, Sudafed PE, & Sinutab Products

Tylenol 8 HourMcNeil Consumer Healthcare is recalling certain lots of TYLENOL® Arthritis Pain, TYLENOL® 8 Hour, and TYLENOL® upper respiratory products, as well as certain lots of BENADRYL®, SUDAFED PE®, and SINUTAB® over-the-counter (OTC) medications distributed at the wholesale level in the United States, the Caribbean, and Brazil.

These OTC drugs were manufactured at the McNeil plant in Fort Washington, PA prior to April 2010, when production at the facility was suspended. McNeil Consumer Healthcare is recalling the products 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.

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 Consumer Healthcare is also recalling certain product lots of ROLAIDS® Multi-Symptom Berry Tablets distributed in the U.S., 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.

Consumers can access full product details and other information about the recall on the www.mcneilproductrecall.com 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).

See the following alerts for background information and related recalls:

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Many of our food, drug and medical device recall alerts come from press releases distributed by the United States Food and Drug Administration (FDA) for public use and redistribution by news outlets likes US Recall News.

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