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RECALL: Children's Motrin, Tylenol, Zyrtec, and Benadryl
5/1/2010

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.

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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

 

Please Note:

Our own PremierValue Brand is not affected by this recall and it's equivalents to the above recalled products are listed here for your reference

         
Product Size Equivalent UPC Check
    Brand Name 11 Digits Digit
Ibuprofen Suspension Drops Berry 1oz Motrin Children's 84098602520 4
Ibuprofen Suspension Berry 4oz Motrin Children's 84098602162 6
Ibuprofen Suspension Bubblegum 4 oz Motrin Children's 84098602351 4
Ibuprofen Suspension Grape 4oz Motrin Children's 84098602350 7
Non-Aspirin Suspension Cherry 4oz Tylenol 84098601367 6
Non-Aspirin Suspension Grape 4oz Tylenol 84098601368 3
Children's Allergy Elixir  4oz Benadryl 84098601396 6
Children's Allergy Elixir  8oz Benadryl 84098601397 3
Children's Non Asp Cough/Nose 4oz Tylenol 84098602214 2
Child's Plus Multi Symptom 4oz Tylenol 84098602288 3