The products 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 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.
McNeil Consumer Healthcare is also initiating a voluntary recall of certain product lots of ROLAIDS Multi-Symptom Berry Tablets distributed in the US, 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.
McNeil identified the inadequacies as part of a thorough, proactive product quality and process assessment of all McNeil produced products.