Safety Alert: Voluntary Recall
September 28, 2009

After discovering the possible contamination with Gram-negative bacteria, Burkholderia cepacia, McNeil Consumer Healthcare, a division of Johnson & Johnson, informed physicians and other providers of the recall in a September 18, 2009 letter. The company reported that no bacteria had been found in finished products, but bacteria were detected in an examination of the bulk materials used to make the medicine.

McNeil cautioned that infection with the bacteria can be serious in high-risk persons, including those with pulmonary disease, cystic fibrosis, or immune systems that are otherwise compromised. Young children and elders using these preparations for pain control should be warned.

The recall covers 21 flavors of its pediatric acetaminophen product, and several cold and cough medications that include acetaminophen, manufactured from April 2008 through June 2008, which includes:

Children's Tylenol® Suspension 4 oz. strawberry, Children's Tylenol® Pediatric Suspension 1 oz. cherry Infants' Tylenol® Suspension Drops 1/2 oz. grape For the complete list and associated lot numbers, see: http://www.tylenol.com/generic.jhtml?id=tylenol/news/subpchildinfantnews.inc.

Individuals who may have these medicines in their possession should:

Stop taking this preparation if listed above. Contact your health care professional (HCP) if you or your child taking this medication has become suddenly ill
Symptoms of exposure can range from no symptoms to severe breathing difficulties especially in those with chronic lung disorders. For more information, visit the CDC website: http://www.cdc.gov/ncidod/dhqp/id_BcepaciaFS.html
Share this information with your HCP, pharmacist and insurance provider should there be additional questions.

The recall does NOT apply to children’s Tylenol® Meltaways or Junior Strength Tylenol® Meltaways.

McNeil has established a consumer call center at 800-962-5357 for parents or caregivers with questions.