OTC Children’s Drug Recall Facts

40 plus OTC childrens drugs recalled

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

Children’s Medicine Recall. Tylenol, Tylenol Plus, Motrin, Zyrtec, Benadryl

Dozens of children’s meds recalled.  Tylenol, Tylenol Plus, Motrin, Zyrtec, Benadryl

More than 40 formulations of children’s medications are being recalled in Canada, the United States and 10 other countries for failing to meet quality standards.

Johnson & Johnson’s corporate headquarters are seen in New Brunswick, N.J. The company’s McNeil Consumer Healthcare subsidiary issued a recall late Friday of major brands of children’s medicine.Johnson & Johnson’s corporate headquarters are seen in New Brunswick, N.J. The company’s McNeil Consumer Healthcare subsidiary issued a recall late Friday of major brands of children’s medicine. (Daniel Hulshizer/Associated Press)

The recall applies to over-the-counter liquid medicines produced by McNeil Consumer Healthcare under the brand names Tylenol, Tylenol Plus, Motrin, Zyrtec and Benadryl.

In Canada, the impact is limited to all lots of Children’s Motrin and infants’ Motrin liquid suspension products and Children’s Tylenol Cough & Runny Nose liquid suspension.

Here is a release describing the Canadian products affected by the recall.

McNeil Consumer Healthcare, a division of consumer-goods giant Johnson & Johnson, issued the recall after consultations with the U.S. Food and Drug Administration.

The FDA doesn’t yet list the recall on its website, nor does Health Canada, but McNeil said in a statement Friday that no adverse health effects have been reported so far as a result of the affected medications.

Rather, the recall has been issued because some of the drugs “may contain a higher concentration of active ingredient than is specified,” while others may be tainted by particles, the company said.

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).

The company is advising consumers to stop giving the products to children as a precautionary measure.

More information is available at www.mcneilproductrecall.com.

Johnson & Johnson issued a major recall of various kinds of adult-grade Tylenol, Motrin, Benadryl and Rolaids last winter when pills became affected by a mouldy smell that made some consumers sick.

Read more: http://www.cbc.ca/health/story/2010/04/30/childrens-medicine-recall.html#ixzz0mselNxkr

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