Some Children's, Infants' Tylenol Recalled
Maker Recalls Certain Lots of Children's and Infants' Tylenol From Warehouses and Retailers; No Illnesses Reported
Sept. 24, 2009 -- McNeil Consumer Healthcare is recalling certain lots of Children's Tylenol and Infants' Tylenol after bulk raw material was found to be tainted with B. cepacia bacteria.
In a news release, the company says it has implemented the voluntary recall "at the warehouse and retail levels," not at the consumer level. "The packaged product, shipped to retailers by the company, has met all specifications," McNeil Consumer Healthcare states.
The recalled products were made between April 2008 and June 2008.
In a letter to healthcare professionals, McNeil Consumer Healthcare states that examination of bulk raw material detected the bacteria Burkholderia cepacia (B. cepacia). But none of that tainted raw material was used in the production of any finished product; the recall is a precaution, according to McNeil Consumer Healthcare.
"Adverse health consequences of B. cepacia infections could be potentially severe, especially in high-risk patients, such as those with underlying pulmonary disease, cystic fibrosis, or compromised immune systems," McNeil Consumer Healthcare states in the letter, which is dated Sept. 18.
The company says it has checked its post-marketing data and found no safety signals for Children's or Infants' Tylenol products for the time period related to the recalled batches.
The likelihood of a serious medical event is "remote," McNeil Consumer Healthcare states.
McNeil Consumer Healthcare advises parents or caregivers to contact their child's health care provider if they have given the product to their child or infant and have concerns. Consumers with questions can also call the company's consumer call center at 800-962-5357 Monday through Friday, from 8 a.m. to 8 p.m. Eastern time.
List of Recalled Children's Tylenol and Infants' Tylenol Products
The recall includes the following Tylenol products (the lot number is on the bottom of the box containing the liquid product and also on the sticker that surrounds the product bottle):
- Children's Tylenol Plus Cold MS Suspension 4 oz. Grape
UPC # 300450391049
Code # 3910400
Lot # SBM041, SBM067, SCM037, SDM027, SEM109
- Children's Tylenol Suspension 4 oz. Grape
Code # 2960400
Lot # SBM042, SCM015, SCM036, SDM034
- Children's Tylenol Suspension 4 oz. Bubble Gum
UPC # 300450407047
Code # 4070400