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Manufacturer issues voluntary recall of pediatric acetaminophen products

McNeil Consumer Healthcare has voluntarily recalled several varieties of children’s Tylenol after concerns that the gram-negative bacteria Burkholderia cepacia may have contaminated some product lots.

Although the bacteria was not found in any finished products, the company wrote in a letter to health care providers earlier this month that B. cepacia was identified in bulk raw materials, and any product manufactured during that time frame was being recalled as a precaution.

The company said that although ingestion of a pharmaceutical product containing B. cepacia is not a documented route of transmission, infection with the bacteria after using contaminated mouthwash and nasal sprays has been reported in the past.

Adverse events can be potentially severe, especially in high-risk patients such as those with underlying pulmonary disease, cystic fibrosis or compromised immune systems.

Patients and health care providers can access a full list of the recalled products on the company’s website.