FDA advice following recall of products
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.
Following McNeil’s recall announcement on Friday 30/04/2010, the FDA is providing 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.
“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.
What products are affected by this recall?The products include certain liquid infant’s and children’s Tylenol®, Motrin®, Zyrtec®, and Benadryl® products.
Why were these products recalled?McNeil Consumer Healthcare is initiating this voluntary recall because some of these products 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.
What can I use instead of the recalled products?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 should discuss this with your pharmacist or other health care professional.
What should I do if I have some of the medication at home?
FDA recommends that consumers stop using these products.
I gave my child some of the medication. What do I do? Is my child at risk?According to the information the FDA has received at this time, the potential for serious medical problems is remote. If your child exhibits any unexpected symptoms after use of any of the recalled products, contact your health care professional.
I gave my child some of the medication. What do I do? Is my child at risk?According to the information the FDA has received at this time, the potential for serious medical problems is remote. If your child exhibits any unexpected symptoms after use of any of the recalled products, contact your health care professional.
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