Some Children's, Infants' Tylenol Recalled

from <a href="http://www.webmd.com" target="_blank">WebMD</a> &#8212; a health information Web site for patients

Miranda Hitti

Disclosures

September 29, 2009

September 29, 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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