Maker Recalls Certain Lots of Children's and Infants' Tylenol From Warehouses and Retailers; No Illnesses Reported
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Reviewed By Louise Chang, MD
In a news release, the company says it has implemented the voluntary recall "at the warehouse and retail levels," not at the consumer level. "The packaged product, shipped to retailers by the company, has met all specifications," McNeil Consumer Healthcare states.
The recalled products were made between April 2008 and June 2008.
In a letter to healthcare professionals, McNeil Consumer Healthcare states that examination of bulk raw material detected the bacteria Burkholderia cepacia (B. cepacia). But none of that tainted raw material was used in the production of any finished product; the recall is a precaution, according to McNeil Consumer Healthcare.
"Adverse health consequences 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 Consumer Healthcare states in the letter, which is dated Sept. 18.
The company says it has checked its post-marketing data and found no safety signals for Children's or Infants' Tylenol products for the time period related to the recalled batches.
The likelihood of a serious medical event is "remote," McNeil Consumer Healthcare states.
McNeil Consumer Healthcare advises parents or caregivers to contact their child's health care provider if they have given the product to their child or infant and have concerns. Consumers with questions can also call the company's consumer call center at 800-962-5357 Monday through Friday, from 8 a.m. to 8 p.m. Eastern time.
List of Recalled Children's Tylenol and Infants' Tylenol Products
The recall includes the following Tylenol products (the lot number is on the bottom of the box containing the liquid 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 4 oz. Grape
Code # 2960400
Lot # SBM042, SCM015, SCM036, SDM034
- Children's Tylenol Suspension 4 oz. Bubble Gum
UPC # 300450407047
Code # 4070400
Lot # SBM043, SBM044, SCM029
- Children's Tylenol Suspension 4 oz. Strawberry
UPC # 300450493040
Code # 4930400
Lot # SBM045, SCM011, SCM030, SDM035
- Infants' Tylenol Grape Suspension Drops 1/4 oz.
Code # 1224000
Lot # SBM064, SCM033, SDM020
- Infants' Tylenol Suspension 1/2 oz. Cherry
UPC # 300450186157
Code # 1861500
Lot # SBM065, SCM005, SCM006, SDM032
- Children's Tylenol Dye Free Suspension 4 oz. Cherry
UPC # 300450166043
Code # 1660400
Lot # SBM066, SCM068
- Children's Tylenol Suspension 4oz. Cherry
UPC Code # 300450123046
Code # 1230400
Lot # SBM068, SCM035, SCM070, SCM080, SDM005
- Children's Tylenol Plus Cough & Runny Nose 4 oz. Cherry
UPC # 300450249043
Code # 2490400
Lot # SBM069, SBM070, SCM081, SDM006
- Infants' Tylenol Suspension Drops 1/2 oz. 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 4 oz. Grape
UPC # 300450387042
Code # 3870400
Lot # SCM016, SFM024
- Children's Tylenol Plus Cough/ST Suspension 4 oz. Cherry
UPC # 300450247049
Code # 2470400
Lot # SCM017
- Infants' Tylenol Suspension Drops 1 oz. Grape
UPC # 300450122018
Code # 1220100
Lot # SCM082, SDM039, SDM040
- Infants' Tylenol Dye Free Suspension 1 oz. Cherry
UPC # 300450167019
Code # 1670100
Lot # SCM083, SCM084, SDM008
- Children's Tylenol Pediatric Suspension 1 oz. Cherry
UPC # 300450123015
Code # 1230100
Lot # SDM064
- Infants' Tylenol Suspension Drops 1 oz. Cherry
UPC # 300450186300
Code # 1863000
Lot # SDM038, SDM009
- Children's Tylenol Plus Cold/Allergy 4 oz. Bubble Gum
UPC # 300450390042
Code # 3900400
Lot # SDM033
- Infants' Tylenol Drops 1 oz. Grape
UPC # 300450122100
Code # 1221000
Lot # SDM078
- Infants' Tylenol Grape Suspension Drops H/G 1/2 oz.
UPC # 350580144183
Code # 1221800
Lot # SCM034
- Children's Tylenol Suspension 4 oz. Cherry, Hospital Gov't.
UPC # 350580123034
Code # 1230300
Lot # SDM028
SOURCES: McNeil Consumer Healthcare, Letter to Healthcare Professionals, Sept. 18, 2009.Statement, McNeil Consumer Healthcare.
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