Working in consultation with the United States Food and Drug Administration (FDA), McNeil Consumer Healthcare is implementing a voluntary recall of infant and children’s liquid products due to manufacturing deficiencies which may affect quality, purity or potency. Some of the manufacturing deficiencies include products that may contain a higher concentration of active ingredient than specified; others that contain inactive ingredients that may not meet internal testing requirements; and others that may contain tiny particles.
Parents and caregivers are advised by the U.S. Food and Drug Administration to stop using these products. Instead, there a number of other products on the market, including generic versions of the recalled products, which are intended for use in infants and children and are not affected by the recall. The FDA states that the potential for serious medical problems is remote. However, if your child exhibits any unexpected symptoms after use of any of the recalled products, contact your health care professional.
Additionally, adverse reactions or quality problems experienced with the use of these products may be reported to FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax, using the contact information at the bottom of this sheet. The agency asks health care professionals and consumers to report any adverse reactions 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. This recall is just the latest.
This past March, McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. recalled certain product lots of Children’s TYLENOL (acetaminophen), and Children’s ZYRTEC (cetirizine HCI) sold in the United States because the bottle plastic was thinner than the company required. Also in March, Infants’ TYLENOL (acetaminophen), Infants’ MOTRIN(ibuprofen), and Children’s ZYRTEC (cetirizine HCI) professional samples distributed in the United States were recalled at the wholesale level because the potential exists for the product lot number and/or expiration date printed on the bottle to become illegible as a result of consumer handling over the life of the product.
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