Some Children's, Infants' Tylenol Recalled

Maker Recalls Certain Lots of Children's and Infants' Tylenol From Warehouses and Retailers; No Illnesses Reported

By Miranda Hitti
WebMD Health News

Reviewed By Louise Chang, MD

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

UPC# 300450296047

Code # 2960400

Lot # SBM042, SCM015, SCM036, SDM034

• Children's Tylenol Suspension 4 oz. Bubble Gum

UPC # 300450407047

Code # 4070400

Lot # SBM043, SBM044, SCM029

• Children's Tylenol Suspension 4 oz. Strawberry

UPC # 300450493040

Code # 4930400

Lot # SBM045, SCM011, SCM030, SDM035

• Infants' Tylenol Grape Suspension Drops 1/4 oz.

UPC# 300450122407

Code # 1224000

Lot # SBM064, SCM033, SDM020

• Infants' Tylenol Suspension 1/2 oz. Cherry

UPC # 300450186157

Code # 1861500

Lot # SBM065, SCM005, SCM006, SDM032

• Children's Tylenol Dye Free Suspension 4 oz. Cherry

UPC # 300450166043

Code # 1660400

Lot # SBM066, SCM068

• Children's Tylenol Suspension 4oz. Cherry

UPC Code # 300450123046

Code # 1230400

Lot # SBM068, SCM035, SCM070, SCM080, SDM005

• Children's Tylenol Plus Cough & Runny Nose 4 oz. Cherry

UPC # 300450249043

Code # 2490400

Lot # SBM069, SBM070, SCM081, SDM006

• Infants' Tylenol Suspension Drops 1/2 oz. Grape

UPC # 300450122155

Code # 1221500

Lot # SCM012, SCM067, SDM007, SDM068

• Children's Tylenol Plus Flu 4oz. Bubble Gum

UPC # 300450386045

Code # 3860400

Lot # SCM013, SCM014, SCM069

• Children's Tylenol Plus Cold Suspension 4 oz. Grape

UPC # 300450387042

Code # 3870400

Lot # SCM016, SFM024

• Children's Tylenol Plus Cough/ST Suspension 4 oz. Cherry

UPC # 300450247049

Code # 2470400

Lot # SCM017

• Infants' Tylenol Suspension Drops 1 oz. Grape

UPC # 300450122018

Code # 1220100

Lot # SCM082, SDM039, SDM040

• Infants' Tylenol Dye Free Suspension 1 oz. Cherry

UPC # 300450167019

Code # 1670100

Lot # SCM083, SCM084, SDM008

• Children's Tylenol Pediatric Suspension 1 oz. Cherry

UPC # 300450123015

Code # 1230100

Lot # SDM064

• Infants' Tylenol Suspension Drops 1 oz. Cherry

UPC # 300450186300

Code # 1863000

Lot # SDM038, SDM009

• Children's Tylenol Plus Cold/Allergy 4 oz. Bubble Gum

UPC # 300450390042

Code # 3900400

Lot # SDM033

• Infants' Tylenol Drops 1 oz. Grape

UPC # 300450122100

Code # 1221000

Lot # SDM078

• Infants' Tylenol Grape Suspension Drops H/G 1/2 oz.

UPC # 350580144183

Code # 1221800

Lot # SCM034

• Children's Tylenol Suspension 4 oz. Cherry, Hospital Gov't.

UPC # 350580123034

Code # 1230300

Lot # SDM028

SOURCES: McNeil Consumer Healthcare, Letter to Healthcare Professionals, Sept. 18, 2009.Statement, McNeil Consumer Healthcare.

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