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Acetaminophen (Tylenol®) Pediatric Liquid Products Recalled Due to Possible Bacterial Contamination

October 1, 2009

McNeil Consumer Healthcare is recalling 57 lots of Children’s and Infants’ Tylenol® (acetaminophen) liquid products because of possible bacterial contamination. Burkholderia cepacia was found in an inactive ingredient; however this ingredient was not used to produce any finished product. The manufacturer is recalling these products as a precaution because they were manufactured during the same time period the bacteria was identified. The affected products were distributed between March 2008 and May 2008.  The affected lot numbers are listed below:

  • Children’s Tylenol Plus Cold MS Suspension
    • Grape, 4 oz: SBM041, SBM067, SCM037, SDM027, SEM109
  • Children’s Tylenol Suspension
    • Cherry, 1oz: SDM064
    • Grape, 4 oz: SBM042, SCM015, SCM036, SDM034,
    • Bubble Gum, 4 oz: SBM043, SBM044, SCM029
    • Strawberry, 4 oz: SBM045, SCM011, SCM030, SDM035
    • Cherry, 4 oz: SBM068, SCM035, SCM070, SCM080, SDM005
    • Cherry, 4 oz, Hospital Government: SDM028 
    • Dye Free Suspension, Cherry, 4oz: SBM066, SCM068
  • Children's Tylenol Plus Cough & Runny Nose 4oz. Cherry: SBM069, SBM070, SCM081, SDM006
  • Children's Tylenol Plus Flu 4oz. Bubble Gum: SCM013, SCM014, SCM069
  • Children's Tylenol Plus Cold Suspension 4oz. Grape: SCM016, SFM024
  • Children's Tylenol Plus Cough/ST Suspension 4oz. Cherry: SCM017
  • Children's Tylenol Plus Cold/Allergy 4oz. Bubble Gum: SDM033
  • Infant’s Tylenol Suspension Drops
    • Grape ¼ oz: SBM064, SCM033, SDM020
    • Grape, ½ oz: SCM012, SCM067, SDM007, SDM068
    • Cherry, ½ oz: SBM065, SCM005, SCM006, SDM032
    • Grape, 1 oz: SCM082, SDM039, SDM040, SDM078
    • Cherry, 1 oz: SDM038, SDM009
    • Grape, ½ oz, Hospital Government: SCM034
    • Dye Free Suspension Cherry, 1 oz: SCM083, SCM084, SDM008

 

Parents and caregivers are advised to contact their healthcare providers if they have given one of these products to their child or infant. Instruct consumers to look for the lot number on the bottle label or on the bottom of the box. For more information, contact the manufacturer’s customer service at 1-800-962-5357.

Additional information is available at the following links:
MedWatch Report:

News Release:

Information from Manufacturer:

Updated
October 1, 2009; September 25, 2009; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.