The FDA announced last night that 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.
Following McNeil’s recall announcement on Friday evening, the FDA is provided additional advice to consumers.
“We want to be certain that consumers discontinue using these products and that they know what to do if they have concerns about a specific product,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “While the potential for serious health problems is remote, Americans deserve medications that are safe, effective and of the highest quality. We are investigating the products and facilities associated with this recall and will provide updates as we learn more.”
McNeil Consumer Healthcare initiated this voluntary recall because some of these products may not meet required quality standards. 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 specified; others 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, FDA advises consumers who have purchased these recalled products to discontinue use.
There are 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. FDA recommends that you check the labeling of these products. If parents or caregivers have any questions, they should discuss them with a pharmacist or other health care professional. FDA does not anticipate that there will be a shortage of alternative products.
Consumers should not give drug products to infants and children that are not intended for those age groups. This could result in serious harm.
FDA recommends that consumers stop using these products and visit McNeil’s website at: www.mcneilproductrecall.com for more information.
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.