The new year isn’t starting well for Johnson & Johnson. First, the OTC drug giant gets sued by the state of Oregon over allegations of a phantom Motrin recall. And now its McNeil Labs division has issued the latest in a lengthy list of actual recalls. This time, it’s for certain lots of Tylenol 8 Hour, Tylenol Arthritis Pain, Tylenol upper respiratory products, Benadryl, Sudafed PE, and Sinutab products distributed in the United States, the Caribbean, and Brazil.
According to the McNeil recall site, all of these products were made at its Fort Washington, PA, plant 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,” reads the announcement. “It is very unlikely that this impacted the quality of these products.”
This is a wholesale-level recall; the company says that no action is required by consumers or healthcare providers and that consumers can continue to use the product. These actions are not being undertaken on the basis of adverse events.
Details on the recalled lots of these products can be found here.
Consumers can access full product details and other information about the recall at www.mcneilproductrecall.com or by calling McNeil’s 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.