40 plus OTC children drugs recalled. Children’s and Infants’ liquid products
According to CNN, more than 40 over-the-counter children’s drugs are being recalled due to the fact they don’t meet quality standards. Those drugs include Tylenol and Motrin among others. The recall was issued after Consumer Healthcare, Division of McNEIL-PPC consulted with the Food & Drug Administration and determined the OTC drugs didn’t measure up in terms of quality.
The voluntary recall applies to all lots that have not yet expired and that were produced in the U.S. for distribution there, in Canada and in 10 other countries. Here are all the affected brands:
* Tylenol Infants’ Drops (7 different formulations).
* Children’s Tylenol Suspensions (8 formulations).
* Children’s Tylenol Plus Suspensions (9 formulations).
* Motrin Infants’ Drops (3 formulations).
* Children’s Motrin Suspensions (11 formulations).
* Children’s Zyrtec Liquids in Bottles (5 formulations).
* Children’s Benadryl Allergy Liquids in Bottles (1 formulation).
According to the Consumer Healthcare organization, the recall is not due to any reported “adverse medical events” but rather as a precautionary measure. Parents shouldn’t use the recalled products for their kids. These include Tylenol Infants’ Drops, Children’s Tylenol Suspensions, Children’s Tylenol Plus Suspensions, Motrin Infant Drops, Children’s Motrin Suspensions, Children’s Zyrtec Liquids in Bottles and Children’s Benadryl Allergy Liquids in Bottles. The drugs were manufactured in the United States and distributed to other countries – Canada, the Dominican Republic, Dubai, Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago and Kuwait.
Consumer Healthcare/McNeil released a press release on Friday with further information about the recall. The press release advises those looking for more information to visit www.mcneilproductrecall.com or call 1-888-222-6036 for more information. A full list of all the affected OTC children’s drugs can be found here at the official press release.
McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children’s Products
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
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