Children's Product Recalls » Medicine

International Vitamin Corporation Recalls Live Better Vitamins Due to Failure to Meet Child-Resistant Closure Requirement

CP_Recalls — Fri, 01 Jul 2011 07:30:39 +0000

The following item is NOT a children’s product, but it represents a child safety issue, as the bottles used are not child-resistant and could be toxic to children, as they contain iron.

Name of Product: Live Better One Daily Tablets and Live Better Complex Vitamin B50 Tablets

Units: About 12,000 units

Manufacturer: International Vitamin Corporation (IVC), of Freehold, N.J.

Hazard: The iron supplements are not in child-resistant packaging as required by the Poison Prevention Packaging Act. Ingesting multiple iron supplement tablets at once can cause serious injury or death to young children.

Incidents/Injuries: No injuries or incidents have been reported.

Description: The recalled supplements were sold in white plastic bottles. “Live Better Complete Multivitamin One Daily Maximum Formula” is printed in blue and red on a white label on one product and “Live Better Complex Vitamin B50″ is printed in blue and green on a white label on the other product.

Sold at: A& P Liquor, A&P, Pathmark, Waldbaum’s, The Food Emporium, Super Fresh and Food Basics grocery stores in CT, NY, NJ, PA, DE, MD, MA, VA and the District of Columbia between June 2009 and October 2010 for about $8.

Manufactured in: United States

Remedy: Consumers should keep this product out of reach of children and call International Vitamin Corporation to receive a free replacement child-resistant cap.

Consumer Contact: For additional information, contact IVC toll-free at (866) 927-5470 between 9 a.m. and 5 p.m. ET Monday through Friday or visit www.ivcinc.com

Women’s Multivitamins Recalled by GNC Due to Failure to Meet Child-Resistant Closure Requirements

CP_Recalls — Fri, 01 Jul 2011 07:21:33 +0000

The following item is NOT a children’s product, but it represents a child safety issue, as the bottles used are not child-resistant and could be toxic to children, as they contain iron.

Name of Product: GNC Women’s Ultra Mega®, Ultra Mega Active, Ultra Mega Energy and Metabolism, and GNC Prenatal Formula with Iron multivitamins

Units: About 2,500

Manufacturer: General Nutrition Corporation of Pittsburgh, Pa.

Hazard: The product contains iron, but does not have child-resistant packaging as required by federal law. If ingested by a child, these vitamins could cause serious injury or death.

Incidents/Injuries: No incidents or injuries have been reported.

Description: This recall only involves the following four products with the noted lot numbers: GNC Women’s Ultra Mega 28-count multivitamin bottles with lot numbers 0432AL1781 and 1283CL1781, GNC Women’s Ultra Mega Active 180-count multivitamin bottles with lot numbers 1029BL1783 and 1030BL1783, GNC Women’s Ultra Mega Energy and Metabolism 90-count multivitamin bottles with lot number 1450CL1789 and GNC Prenatal Formula with Iron 120-count multivitamin bottles with lot number 0785BL2863. The lot numbers are printed on the side of the bottle and on the bottom of the product’s packaging. The affected lots are packaged in a white plastic bottle with a white label and a flip-top cap.

Sold exclusively at: GNC retail stores nationwide and at the GNC website from March 2011 through May 2011 for between approximately $9 and $35.

Manufactured in: United States

Remedy: Consumers should keep these products out of the reach of children and return them to the GNC store where they were purchased to be exchanged for a replacement bottle or refund.

Consumer Contact: For additional information, consumers can contact GNC toll-free at (888) 462-2548 anytime, or visit the firm’s website at www.gnc.com

Lot Number on Packaging

Lot Number on Bottle

Rugby Children’s Pain & Fever Concentrated Drops Recalled Due To Failure to Meet Child-Resistant Closure Requirement

CP_Recalls — Fri, 24 Jun 2011 05:16:39 +0000

Name of Product: Children’s Pain & Fever Concentrated Drops

Units: About 898,000

Manufacturer: Altaire Pharmaceuticals, Inc., of Aquebogue, N.Y

Distributed by: Rugby Laboratories, Inc., of Duluth, Georgia

Hazard: This over the counter medicine contains acetaminophen which calls for child-resistant packaging as required by the Poison Prevention Packaging Act. Although the original bottle has child-resistant packaging, a separate dropper unit provided for dispensing the drug to children does not. When in use, a child can access the medicine, posing serious health problems or death if more than the recommended dosage is consumed.

Incidents/Injuries: None reported

Description: The recall involves Rugby Children’s Pain & Fever Concentrated Drops (Acetaminophen Drops) in a 1/2 fl. oz. (15 ml) bottle size. The UPC code 305361936723 can be found with the bar code at the bottom of the box. The affected lot numbers are:

09002	09379	10272	10368	10487
09131	09394	10273	10406	11058
09215	10154	10366	10433

The lot numbers can be found stamped into the bottom of the carton with the expiration date and above the label on the bottle printed in black.

Sold at: Drug stores, grocery stores and other retailers nationwide between January 2009 and June 2011 for about $4.

Manufactured in: United States

Remedy: Consumers should immediately store this product with the child-resistant closure in place and keep it out of the reach of children. To arrange for a free replacement dropper, contact Altaire Pharmaceuticals at (800) 258-2471 9 a.m. to 5 p.m. ET Monday through Friday.

Consumer Contact: For additional information, contact Rugby Laboratories at (800) 645-2158 between 9 a.m. and 5 p.m. ET Monday through Friday.

Working with FDA, Standard Homeopathic Company Voluntarily Recalls Hyland’s Teething Tablets to Address Manufacturing Process

CP_Recalls — Sat, 23 Oct 2010 23:42:56 +0000

Standard Homeopathic Company, in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling its Hyland’s Teething Tablets. The company is initiating this recall in an abundance of caution due to an FDA investigation of its manufacturing facility. Hyland’s Teething Tablets are manufactured in the United States and distributed throughout North America.

The Hyland’s Teething Tablets UPC codes included in the recall are:

1. Hyland’s Teething Tablets, 125 tablets, UPC # 3 54973 75041
2. Hyland’s Teething Tablets, 250 tablets, UPC # 3 54973 75042
3. Hyland’s Teething Tablets, 125 tablets, UPC # 3 54973 75066
4. Hyland’s Teething Tablets, 50 tablets, UPC # 3 54973 75044
5. Hyland’s Teething Tablets, 145 tablets, UPC # 3 54973 75121
6. Hyland’s Teething Tablets, Clip Strip 6×125 tablets, UPC # 3 54973 35109

Adverse events have been reported but the FDA has said that a conclusive link has NOT been determined. The company, in working with the FDA, has identified manufacturing processes of Teething Tablets that can be improved to ensure uniformity in dosage. As a homeopathic product, Hyland’s Teething Tablets have a wide margin of safety that protects consumers from harm.

After in-depth analysis, a comprehensive review of the company’s adverse event report log, and more than 85 years of safe usage, the company is confident that Hyland’s Teething Tablets are safe for infants and toddlers.

In addition to the product recall, Standard Homeopathic Company is refining its production, packaging and testing protocols. Throughout the process, Standard Homeopathic Company will continue to closely monitor and evaluate the situation and consult with FDA.

Consumers that are concerned about the safety of the product may contact Standard Homeopathic Company for instructions on a refund or replacement product. For these instructions or information regarding how to return or dispose of the product, consumers should log on to www.hylandsteething.com/recall or call 1-877-496-5044 (Monday-Friday 9 a.m. to 5 p.m. Eastern Time, and Saturday-Sunday 10 a.m. to 4 p.m. Eastern Time).

“We initiated this voluntary recall to ensure our consumers know that their families’ safety and health are our top priorities,” said Mark Phillips, PharmD, President and Chief Pharmacist of Standard Homeopathic Company. “We are committed to maintaining and deserving the trust they have placed in Hyland’s. We have worked for 107 years to build relationships with our consumers. We intend to preserve that tradition of trust.”

Hyland’s Teething Tablets is a homeopathic product intended to provide temporary relief of teething symptoms in children that is sold over-the-counter (OTC) in retail outlets.

No other Standard Homeopathic Company products are affected by this recall.

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, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

With over 100 years of experience in providing families with access to safe, natural, reliable medicines, Standard Homeopathic Company and its division, Hyland’s, Inc., have many symptom fighting products consumers have come to trust. For more information on their line of products, visit www.hylands.com or www.facebook.com/Hylands.Health.

About Standard Homeopathic Company

Standard Homeopathic Company develops and manufacturers lines of homeopathic medicines, including its top-selling Hyland’s brand. Hyland’s homeopathic formulas are manufactured with the highest quality natural ingredients following the strictest standards of preparation. With over a century of commitment, Standard Homeopathic Company’s tradition of excellence consistently provides quality and integrity in every product. From Hyland’s Teething Tablets to Hyland’s Calms Forté, Standard Homeopathic Company cares for your family at every stage of life. Consumers can trust Standard Homeopathic Company’s products to be natural, gentle, effective and safe for the entire family.

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

###

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.

###

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.