McNeil Consumer Healthcare, a division of McNEIL-PPC, part of Johnson & Johnson (J&J, New Brunswick, NJ) issued a voluntary recall on Dec. 9, 2010, for Rolaid products in the United States and Canada due to reports of possible product contamination. The recall is the latest of several product recalls by J&J’s consumer healthcare business relating to problems in quality control and quality assurance in its manufacturing activities.
McNeill is voluntarily recalling of lots of Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews, and Rolaids Multi-Symptom plus Anti-Gas Softchews distributed in the United States. McNeil also is voluntarily recalling all lots of Rolaids Ultra Strength SoftChews and Rolaids Ultra Strength SoftChews plus Gas Relief distributed in Canada.
McNeil said it is taking this action following some consumer reports of foreign materials in the product, including metal and wood particles. McNeill said that a company investigation has determined that the materials were potentially introduced into the product during the manufacturing process at a third-party manufacturer. The company also has suspended production of these products and said it will not restart production until corrective actions have been implemented.
See related stories:
A Timeline of J&J/McNeil’s Recent Recall Troubles (PharmTech blog)
FDA Testifies to Congress Regarding J&J Recalls, Quality Concerns (ePT)
J&J Voluntarily Recalls Certain OTC products (ePT)
J&J Voluntarily Recalls Certain OTC Products Because of Manufacturing Problems (ePT)