McNeil Recalls Products for Cleaning Concerns Based on “Comprehensive Action Plan” Review

McNeil’s findings under its “Comprehensive Action Plan” (CAP) of cleaning issues at its Fort Washington, PA plant has resulted in another round of over-the-counter (OTC) product recalls.

In a mid-January release, the company announced that it was initiating a recall of various lots of Tylenol, Sudafed and Benadryl 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.”

McNeil maintained in the release that it is “very unlikely” that the cleaning issues impacted the quality of the recalled products. The firm has indicated that about 43 million packages are involved in the recall.

The products were manufactured at the Fort Washington facility prior to April 2010, when production at the plant was suspended following an extended inspection and 483 by FDA (IPQ “In the News” May 6, 2010).

McNeil also reported that it was recalling about 4 million packages of Rolaids tablets for which the labeling needed to be updated to include “does not meet USP” as required by regulation.

Both recalls are being conducted to the wholesale level. McNeil stressed in the release that the actions “are not being undertaken on the basis of adverse events” and that consumers can continue to use the products.

[More on McNeil’s CAP implementation process and related cleaning concerns is provided for subscribers here.  Nonsubscribers can purchase the full story for $95 by contacting Karen Bertani (  For IPQ subscription/license information, click here.]