Johnson & Johnson's McNeil unit is voluntarily recalling 57 lots of infants' and children's liquid Tylenol products because of possible bacterial contamination.
The products being recalled were made between April and June and include nearly two dozen varieties, including Children's Tylenol Suspension 4 oz. Grape, Infants' Tylenol Grape Suspension Drops 1/4 oz. and Children's Tylenol Plus Cold/Allergy 4 oz. Bubble Gum.
Johnson & Johnson said late Thursday it has contacted wholesalers and retailers about the recall. An inactive ingredient didn't meet internal testing requirements, the company said, and B. cepacia bacteria were detected in a portion of raw material that went unused in the finished product.
The company said in a letter that no bacteria were found in the finished product, and that the likelihood of a serious medical event is remote. But it said it decided after consulting with the Food and Drug Administration that it would recall the products.
"It was decided, as a precaution, 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," the company said.
Consumers with questions should call McNeil's consumer call center at 1-800-962-5357.
Lot numbers can be found on the bottom of the product's box and on the sticker that surrounds the product's bottle.
A full list of the recalled products and lot numbers is available to Tylenol's web siteYou may have heard that 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. All products manufactured met internal specifications. However, the company is implementing this recall because during this period, an unused portion of one inactive ingredient did not meet all quality standards. Therefore, as a precautionary measure, it was decided to recall all Children's and Infants' TYLENOL® liquid products listed below, which were made during this time.
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.