Safety Alerts & Recalls
What does this mean?
The manufacturer and the FDA have determined that any recalled product that may have been purchased by consumers does not pose a significant health risk. No action is required by consumers or healthcare providers and consumers can continue to use the product. Consumers can access full product details and other information about the recall by calling the McNeil 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) or by visiting the website: www.mcneilproductrecall.com.
Any adverse reactions may be reported to the FDA's MedWatch Adverse Event Reporting program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
McNeil Consumer Healthcare Initiates Voluntary Recall of Certain Over-The-Counter (OTC) Products
Following on from previous recall alerts, McNeil Consumer Healthcare, a Division of McNEIL-PPC, Inc. is recalling certain lots of Tylenol 8 Hour, Tylenol Arthritis Pain, Tylenol Cold, Tylenol Allergy, Tylenol Sinus, and certain lots of Benadryl, Sudafed PE, and Sinutab products in consultation with the Food and Drug Administration (FDA). 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 a complete review of past production records found instances where equipment cleaning procedures were not satisfactory or that cleaning was not correctly documented. It is very unlikely that this impacted the quality of these products. This recall is not being issued because of adverse events.
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