McNeil Consumer Healthcare -English

McNeil Consumer Healthcare Reminds Consumers to Check Whether Pediatric Liquid Medicines Were Part of the April 30 2010 Recall

May 2010) – McNeil Consumer Healthcare, reminds parents and caregivers to check their infants’ and children’s forms of TYLENOL®, MOTRIN®, ZYRTEC® and BENADRYL® after the April 30, 2010 voluntary recall. View list of recalled products here.

McNeil Consumer Healthcare initiated the voluntary recall because some of these products did not meet required quality standards. The recall was not undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not to 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 reminds consumers who have purchased these recalled products to discontinue use.
The company has conducted 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.
McNeil encourages consumers to contact the company’s Consumer Care Center at 1-888-222-6036 or to visit www.mcneilproductrecall.com for more information on the recall, to receive a refund or coupon, and for information about proper disposal of recalled products. 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 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


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