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NEW WARNING
McNeil Consumer Healthcare issued a "Dear Health Care Professional" letter to warn of a voluntary recall of certain lots of Children's and Infant's Tylenol. The products, manufactured between April and June 2008, contained inactive ingredients that didn't meet internal testing requirements. Specifically, gram-negative bacteria Burkholderia cepacia were detected. Bacteria weren't detected in the final product, which met all specifications.
Literature shows that ingestion of B. cepacia through contaminated products hasn't been the route of transmission of B. cepacia infection. However, infection has been associated with contaminated nasal sprays and mouthwash. B. cepacia infection has the potential to be severe in high-risk patients, such as those with underlying pulmonary disease, cystic fibrosis, or compromised immune systems. McNeil has conducted postmarketing surveillance, and no safety concerns were identified during the introduction of these products. However the company is advising parents and caregivers who are concerned because they've administered the product to contact their health care providers.
The affected lot numbers include SBM041, SBM067, SCM037, SDM027, SEM109, SBM042, SCM015, SCM036, SDM034, SBM043, SBM044, SCM029, SBM045, SCM011, SCM030, SDM035, SBM064, SCM033, SDM020, SBM065, SCM005, SCM006, SDM032, SBM066, SCM068, SBM068, SCM035, SCM070, SCM080, SDM005, SBM069, SBM070, SCM081, SDM006, SCM012, SCM067, SDM007, SDM068, SCM013, SCM014, SCM069, SCM016, SFM024, SCM017, SCM082, SDM039, SDM040, SCM083, SCM084, SDM008, SDM064, SDM038, SDM009, SDM033, SDM078, SCM034, and SDM028. Consumers who have the affected product should contact McNeil's Customer Care Center at 1-800-962-5357 to get a coupon for a new bottle. Questions can be answered by calling the Medical Affairs Department at 1-800-962-5357.
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