NJLINCS Health Alert Network
Public Health Info
Distributed by the New Jersey Department of Health and Senior Services
Please review the following message from Alan Talarsky, Environmental Scientist 1, Food and Drug Safety Program, DHSS regarding the following Class 1 Recall of various Children's and Infant's Tylenol Products by the manufacturer, McNeil Consumer Healthcare.
McNeil Consumer Healthcare (the makers of TYLENOL®) is voluntarily recalling certain lots of Children's and Infants' TYLENOL® liquid products that were manufactured between April, 2008 and June, 2008. In a written statement, McNeil Consumer Healthcare, Tylenol's manufacturer, said it detected bacteria in an inactive ingredient. While that ingredient was not used in any packaged final products, it was produced at the same time as those products.
In consultation with the U.S. Food and Drug Administration, McNeil, a subsidiary of Johnson and Johnson, decided to recall all product that utilized any of the raw material manufactured at the same time as the raw material that tested positive for the bacteria as a precaution, adding that "the likelihood of a serious medical event is remote."
According to McNeil's statement, scientific literature about the bacteria suggests that ingesting a contaminated pharmaceutical product orally doesn't trigger an infection, but use of products such as a nasal spray with the bacteria has lead to infections.
Parents and caregivers who have questions or concerns should contact their child's health care provider or our consumer call center at 1-800-962-5357 (available Monday-Friday 8 a.m. to 8 p.m. Eastern Time). Consumers can find the lot numbers on the bottom of the box containing the liquid product and also on the sticker that surrounds the product bottle. The lot numbers of the affected products are listed below.
These actions do not apply to Children's TYLENOL® Meltaways and Junior Strength TYLENOL® Meltaways. The voluntary recall applies only to select lots of Children's and Infants' TYLENOL® liquid products.
Recalled Products - Full List
Lot # Product Description
SBM041, SBM067, SCM037, SDM027, SEM109 Children's Tylenol Plus Cold MS Suspension 4 oz. Grape
SBM042, SCM015, SCM036, SDM034 Children's Tylenol Suspension 4oz. Grape
SBM043, SBM044, SCM029 Children's Tylenol Suspension 4oz. Bubble Gum
SBM045, SCM011, SCM030, SDM035 Children's Tylenol Suspension 4oz. Strawberry
SBM064, SCM033, SDM020 Infant's Tylenol Grape Suspension Drops 1/4oz.
SBM065, SCM005, SCM006, SDM032 Infant's Tylenol Suspension 1/2oz. Cherry
SBM066, SCM068 Children's Dye Free Suspension 4oz. Cherry
SBM068, SCM035, SCM070, SCM080, SDM005 Children's Tylenol Suspension 4oz. Cherry
SBM069, SBM070, SCM081, SDM006 Children's Tylenol Plus Cough & Runny Nose 4oz. Cherry
SCM012, SCM067, SDM007, SDM068 Infant's Tylenol Suspension Drops 1/2oz. Grape
SCM013, SCM014, SCM069 Children's Tylenol Plus Flu 4oz. Bubble Gum
SCM016, SFM024 Children's Tylenol Plus Cold Suspension 4oz. Grape
SCM017 Children's Tylenol Plus Cough/ST Suspension 4oz. Cherry
SCM082, SDM039, SDM040 Infant's Tylenol Suspension Drops 1oz. Grape
SCM083, SCM084, SDM008 Infant's Tylenol Dye Free Suspension 1oz. Cherry
SDM064 Children's Tylenol Pediatric Suspension 1oz. Cherry
SDM038, SDM009 Infant's Tylenol Suspension Drops 1oz. Cherry
SDM033 Children's Tylenol Plus Cold/Allergy 4oz. Bubble Gum
SDM078 Infant's Tylenol Drops 1oz. Grape
SCM034 Infant's Tylenol Grape Suspension Drops H/G 1/2oz.
SDM028 Children's Tylenol Suspension 4oz. Cherry, Hospital Govt.
No action is required of local health departments at this time for this recall. If any requests for assistance are received from FDA, the Food and Drug Safety Program will contact you. For additional information regarding warnings and recalls, please click on the weblink below.
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For all recalls - http://www.recalls.gov/recent.html
