Children's Product Recalls » Tylenol

MCNEIL CONSUMER HEALTHCARE ANNOUNCES VOLUNTARY RECALL OF CERTAIN OVER-THE-COUNTER (OTC) PRODUCTS IN THE UNITED STATES, FIJI, GUATEMALA, DOMINICAN REPUBLIC, PUERTO RICO, TRINIDAD & TOBAGO, AND JAMAICA

CP_Recalls — Thu, 08 Jul 2010 23:46:05 +0000

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling 21 lots of over-the-counter medicines. The lots involved, listed below, are sold in the United States, Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidad & Tobago, and Jamaica. This action is a follow-up to a product recall that McNeil Consumer Healthcare originally announced on January 15, 2010, which was initiated following consumer complaints of a musty or moldy odor, which has been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). The risk of serious adverse medical events is remote. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

These lots are being added to the list of recalled products as a precautionary measure after a continuing internal review determined that some packaging materials used in the lots had been shipped and stored on the same type of wooden pallet that was tied to the presence of TBA in earlier recalled lots. All lots involved in the recall were produced before the January 15, 2010 recall, after which McNeil stopped accepting shipments of materials from its suppliers on that type of pallet.

Consumers who purchased product from the lots included in this recall should stop using the product and contact McNeil Consumer Healthcare for instructions on a refund or replacement. For these instructions, and information regarding how to return or dispose of the product, consumers should log on to the internet at www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Consumers who have medical concerns or questions should contact their healthcare provider.

Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/safety/medwatch/default.htm.

The product lot numbers for the recalled products can be found on the side of the bottle label.

FULL RECALLED PRODUCT LIST:

Product Name Lot Number UPC Code
BENADRYL® ALLERGY ULTRATAB™
BENADRYL® ALLERGY ULTRATAB™ TABLETS 100 count ABA567 312547170338
BENADRYL® ALLERGY ULTRATAB™ TABLETS 100 count ABA574 312547170338
Children’s TYLENOL® Meltaways
CHILDREN’S TYLENOL® MELTAWAYS BUBBLEGUM 30 count ABA544 300450519306
MOTRIN® IB
MOTRIN® IB CAPLET 24 count ACA003 300450481030
MOTRIN® IB CAPLET bonus pack 50+25 count ACA002 300450481764
MOTRIN® IB TABLET 100 count AFA060 300450463043
TYLENOL®, Extra Strength
TYLENOL®, Extra Strength EZ TABLET 225 count ASA206 300450422378
TYLENOL®, Extra Strength EZ TABLET 50 count ABA005 300450422507
TYLENOL®, Extra Strength COOL CAPLET 24 count ABA566 300450444240
TYLENOL®, Extra Strength CAPLET bonus pack 24+12 count ACA025 300450444318
TYLENOL®, Extra Strength CAPLET 50 count AFA018 300450449078
TYLENOL®, Extra Strength CAPLET 50 count
(included in Day/Night Pack) ABA168 300450444530
TYLENOL®, Day & Night Value Pack
(contains Extra Strength CAPLET 50 count
Lot # ABA168 & UPC 300450444530) AEC005 300450527103
TYLENOL®, Day & Night Value Pack
(contains Extra Strength CAPLET 50 count
Lot # ABA168 & UPC 300450444530) AFC005 300450527103
TYLENOL®, Day & Night Value Pack
(contains Extra Strength CAPLET 50 count
Lot # ABA168 & UPC 300450444530) ADC002 300450527103
TYLENOL®, Extra Strength RAPID RELEASE GELCAP 24 count ACA024 300450488244
TYLENOL®, Extra Strength RAPID RELEASE GELCAP 225 count AJA119 300450488251
TYLENOL® PM
TYLENOL® PM CAPLET 24 count ACA005 300450482242
TYLENOL® PM CAPLET 24 count ADA259 300450482242
TYLENOL® PM GELTAB 50 count AFA100 300450176509
TYLENOL® PM RAPID RELEASE GELCAP 20 count ACA004 300450244208

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CLICK HERE FOR RECALL INFORMATION ON CERTAIN PRODUCT LOTS OF OVER-THE-COUNTER PRODUCTS RECALLED ON JANUARY 15, 2010, JUNE 15, 2010 AND JULY 8, 2010.

McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children’s Products

CP_Recalls — Sat, 01 May 2010 06:28:03 +0000

Fort Washington, PA (April 30, 2010) – McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling all lots that have not yet expired of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait. (SEE RECALLED PRODUCT LIST BELOW).

McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use.

The company is conducting a comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before new manufacturing is initiated at the plant where the recalled products were made.

Consumers can contact the company at 1-888-222-6036 and also at www.mcneilproductrecall.com. Parents and caregivers who are not sure about alternative pediatric health treatment options should talk to their doctor or pharmacist and are reminded to never give drug products to infants and children that are not intended for those age groups as this could result in serious harm.

For additional information, including affected NDC numbers, consumers should visit our website www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

McNeil Consumer Healthcare, Division of McNeil-PPC, Inc. markets a broad range of well-known OTC products.

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CLICK HERE FOR RECALL INFORMATION ON CERTAIN INFANTS’ TYLENOL® AND CHILDREN’S TYLENOL® PRODUCTS

CLICK HERE FOR RECALL INFORMATION ON CERTAIN INFANTS’ MOTRIN® AND CHILDREN’S MOTRIN® PRODUCTS

CLICK HERE FOR RECALL INFORMATION ON CERTAIN CHILDREN’S ZYRTEC® PRODUCTS

CLICK HERE FOR RECALL INFORMATION ON CERTAIN CHILDREN’S BENADRYL® PRODUCTS

CLICK HERE FOR INFORMATION ON ALL RECALLED PRODUCTS FROM APRIL 30, 2010

CLICK HERE TO REQUEST A REFUND OR PRODUCT COUPON

CLICK HERE TO SEE FREQUENTLY ASKED QUESTIONS

Select Lots Of Children’s And Infant’s Liquid TYLENOL® Recalled

CP_Recalls — Thu, 24 Sep 2009 07:18:47 +0000

Children's Tylenol

This information was posted on the Tylenol web site.

You 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.
*This product may be contained in certain JOHNSON’S® Baby Relief Kits. Please check the lot number on the Tylenol bottle in your kit to determine if it is included in this recall.