Recall of Certain Lots of Children’s and Infants Tylenol® Products. Company Cites Concerns About Inactive Bacteria Found During Manufacturing Process.
On September 18, 2009, McNeil Consumer Healthcare, the makers of Tylenol®, announced a voluntary recall of certain lots of Children’s and Infants Tylenol® products. The recall was initiated after bacteria was found in an inactive ingredient in products manufactured between April and June 2008.
The communication was sent to healthcare professionals to advise that the voluntary recall was taking place due to an internal investigation that led to the discovery that bulk raw material detected that one of the inactive ingredients did not meet the company’s internal testing requirements.
The following information from McNeil’s letter to healthcare professionals, along with the complete list of the recalled products, follows below. Consumers can locate the lot numbers for the affected products on both the bottom of the container box and the sticker surrounding the product bottle.
The gram-negative bacteria Burkholderia cepacia (B. cepacia) was detected. The portion of raw material in which the bacteria was found was isolated and was not used in the production of any finished product. However, it was decided, as a precaution, to recall all products that utilized any of the raw material manufactured at the same time as the raw material that tested positive for the bacteria. Please note: No bacteria has been detected in finished product and the finished product has met all specifications.
A review of the relevant published scientific literature regarding B. cepacia indicates that while ingestion of contaminated pharmaceutical product is not known to be a route of transmission of B. cepacia infection, infection has been reported following the use of contaminated pharmaceutical products such as mouthwashes and nasal sprays. Adverse health consequence 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 has conducted an assessment of post-marketing safety surveillance data and did not identify any safety signals or batch-related safety concerns for Infants' and Children's TYLENOL® products over the time period, starting with the introduction of these batches, in or around April 2008.
McNeil is advising parents and caregivers who have administered affected product to their child or infant and have concerns to contact their healthcare providers. Parents and caregivers can find the lot numbers on the bottom of the box containing the 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 4oz. Grape
UPC # 300450296047
Code # 2960400
Lot # SBM042, SCM015, SCM036, SDM034
Children's Tylenol Suspension 4oz. Bubble Gum
UPC # 300450407047
Code # 4070400
Lot # SBM043, SBM044, SCM029
Children's Tylenol Suspension 4oz. Strawberry
UPC # 300450493040
Code # 4930400
Lot # SBM045, SCM011, SCM030, SDM035
Infant’s Tylenol Grape Suspension Drops 1/4oz.
UPC # 300450122407
Code # 1224000
Lot # SBM064, SCM033, SDM020
Infant's Tylenol Suspension 1/2oz. Cherry
UPC # 300450186157
Code # 1861500
Lot # SBM065, SCM005, SCM006, SDM032
Children's Dye Free Suspension 4oz. Cherry
UPC # 300450166043
Code # 1660400
Lot # SBM066, SCM068
Children's Tylenol Suspension 4oz. Cherry
UPC # 300450123046
Code # 1230400
Lot # SBM068, SCM035, SCM070, SCM080, SDM005
Children's Tylenol Plus Cough & Runny Nose 4oz. Cherry
UPC # 300450249043
Code # 2490400
Lot # SBM069, SBM070, SCM081, SDM006
Infant's Tylenol Suspension Drops 1/2oz. 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 4oz. Grape
UPC # 300450387042
Code # 3870400
Lot # SCM016, SFM024
Children's Tylenol Plus Cough/ST Suspension 4oz. Cherry
UPC # 300450247049
Code # 2470400
Lot # SCM017
Infant's Tylenol Suspension Drops 1oz. Grape
UPC # 300450122018
Code # 1220100
Lot # SCM082, SDM039, SDM040
Infant's Tylenol Dye Free Suspension 1oz. Cherry
UPC # 300450167019
Code # 1670100
Lot # SCM083, SCM084, SDM008
Children’s Tylenol Pediatric Suspension 1oz. Cherry
UPC # 300450123015
Code # 1230100
Lot # SDM064
Infant's Tylenol Suspension Drops 1oz. Cherry
UPC # 300450186300
Code # 1863000
Lot # SDM038, SDM009
Children's Tylenol Plus Cold/Allergy 4oz. Bubble Gum
UPC # 300450390042
Code # 3900400
Lot # SDM033
Infant's Tylenol Drops 1oz. Grape
UPC # 300450122100
Code # 1221000
Lot # SDM078
Infant’s Tylenol Grape Suspension Drops H/G 1/2oz.
UPC # 350580144183
Code # 1221800
Lot # SCM034
Children's Tylenol Suspension 4oz. Cherry, Hospital Govt.
UPC # 350580123034
Code # 1230300
Lot # SDM028
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