Johnson & Johnson's (J&J) McNeil Consumer Healthcare Division has announced another round of recalls, this one involving about 47m units of over-the-counter medicines including popular brands like the painkiller Tylenol (acetaminophen), the decongestant Sudafed (pseudoephedrine) and the antacid Rolaids (calcium carbonate and magnesium). The recall is aimed at wholesalers and requires no action on the part of consumers, the company noted.
The problems with the products – faulty cleaning procedures for the equipment that made the Tylenol and Sudafed units and labelling omissions for the Rolaids units – were identified as part of a review of a Pennsylvania manufacturing facility that was shut down in April of last year after deficiencies led to earlier recalls.
J&J conducted the review as a component of the comprehensive action plan on quality improvement that it submitted to the US Food and Drug Administration (FDA) last year in the wake of a string of recalls of McNeil's over-the-counter products. "As part of this commitment, McNeil undertook a thorough investigation of historical records, as far back as 2007, for products sold in the US and produced in McNeil's internal manufacturing network," J&J explained. "For each product, McNeil looked at whether the right processes had been identified and followed, and evaluated whether quality standards had been met."
McNeil is still in the process of conducting similar assessments at additional manufacturing sites. "If these reviews reveal any further issues, McNeil will not hesitate to take whatever steps are needed to ensure that its products meet world-class quality standards, including further market action if warranted," the company said.
The latest recall announcement comes just days after Oregon's attorney general filed a lawsuit against J&J charging that McNeil exposed consumers in the state to defective supplies of the over-the-counter painkiller Motrin (ibuprofen) by delaying a full public recall of the drug even after it became clear that problems existed, opting instead to hire contractors to attempt to buy up supplies from store shelves. The "phantom recall" at the centre of the lawsuit is also being investigated by the US House Committee on Oversight and Government Reform.