Johnson & Johnson Recalls More Tylenol, Other Over-the-Counter Drugs

More <"">over-the-counter drugs are being recalled by Johnson & Johnson’s McNeil Consumer Healthcare unit. This time, the drug maker is recalling 43 million bottles of certain Tylenol 8 Hour, Tylenol Arthritis Pain, and Tylenol upper respiratory products, as well as Benadryl, Sudafed PM and Sinutab products distributed in the United States, the Caribbean, and Brazil.

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 said it was 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.

Some lots of Rolaids tablets have also been recalled by McNeil because they do not include certain labeling information.

In the past year, McNeil has recalled more than 200 million bottles of over-the-counter medicine. Many of the recalled products were made at McNeil’s Fort Washington, Pennsylvania facility, which was temporarily closed last year because of quality issues. The plant is expected to stay closed well into next year, and 75 percent of its workforce has been laid off.

Johnson & Johnson said in a statement Friday that the latest recalls were the result of a comprehensive action plan, submitted to the U.S. Food& Drug Administration (FDA) last summer, to bring its manufacturing operations into compliance with federal standards.

According to the Johnson & Johnson statement, 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.

No adverse events have been reported in relation to these drugs, the statement said.

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

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