Saturday, September 26, 2009

Recall of Certain Lots of Infants' and Children's TYLENOL Products

Did you buy TYLENOL brand infant's or children's products between April 2008 and June 2008? Certain lots are being recalled by the company, McNeil, because when they examined the bulk raw material, they found that one of the inactive ingredients did not meet internal testing requirements. A type of gram-negative bacteria, B. cepacia, was found and isolated in this portion of raw material. NOTE: no bacteria were detected in any of the finished products, but, as a precaution, the company has volunteered to recall all product made when that particular batch of raw material was present in the factory. Again, no need to panic because the bottle you have at home does not contain bacteria and it was not made from that specific batch of raw material. No side effects have been reported to the company or FDA from these products. Also, one cannot get an infection from this bacteria by taking the medicine. If your child has an underlying lung disease, cystic fibrosis, or a weaker immune system, the bacteria could cause adverse effects. To check to see if the bottle you have at home is being recalled, look for the lot number at the bottom of the box that came with the bottle, or on the sticker that surrounds the bottle. Below is the complete list of recalled lots. If you determine that you have the affected product, please call McNeil's Customer Care Center at 1-800-962-5357 to be sent a coupon for a new bottle. Please contact your child's doctor if you have specific concerns or if you have recently given your child Tylenol purchased during April and June 2008.

Lot #Product Description
SBM041, SBM067, SCM037, SDM027, SEM109Children's Tylenol Plus Cold MS Suspension 4 oz. Grape
SBM042, SCM015, SCM036, SDM034Children's Tylenol Suspension 4oz. Grape
SBM043, SBM044, SCM029Children's Tylenol Suspension 4oz. Bubble Gum
SBM045, SCM011, SCM030, SDM035Children's Tylenol Suspension 4oz. Strawberry
SBM064, SCM033, SDM020Infant’s Tylenol Grape Suspension Drops 1/4oz.
SBM065, SCM005, SCM006, SDM032Infant's Tylenol Suspension 1/2oz. Cherry
SBM066, SCM068Children's Dye Free Suspension 4oz. Cherry
SBM068, SCM035, SCM070, SCM080, SDM005Children's Tylenol Suspension 4oz. Cherry
SBM069, SBM070, SCM081, SDM006Children's Tylenol Plus Cough & Runny Nose 4oz. Cherry
SCM012, SCM067, SDM007, SDM068Infant's Tylenol Suspension Drops 1/2oz. Grape
SCM013, SCM014, SCM069Children's Tylenol Plus Flu 4oz. Bubble Gum
SCM016, SFM024Children's Tylenol Plus Cold Suspension 4oz. Grape
SCM017Children's Tylenol Plus Cough/ST Suspension 4oz. Cherry
SCM082, SDM039, SDM040Infant's Tylenol Suspension Drops 1oz. Grape
SCM083, SCM084, SDM008Infant's Tylenol Dye Free Suspension 1oz. Cherry
SDM064Children’s Tylenol Pediatric Suspension 1oz. Cherry
SDM038, SDM009Infant's Tylenol Suspension Drops 1oz. Cherry
SDM033Children's Tylenol Plus Cold/Allergy 4oz. Bubble Gum
SDM078Infant's Tylenol Drops 1oz. Grape
SCM034Infant’s Tylenol Grape Suspension Drops H/G 1/2oz.
SDM028Children's Tylenol Suspension 4oz. Cherry, Hospital Govt.

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