Recall of Certain Infants' and Children's OTC products (4/30/10)

How do I find NDC number, lot number and expiration date?

Product NDC numbers can be located on the label of the bottle above the brand name. Lot Numbers and Expiration Dates can be found on back / side label of the bottle. If you cannot find the NDC numbers and LOT numbers/expiration dates on the label, Click here for examples.

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Should I return recalled product to retail stores for a refund?


No. You do not need to return recalled product(s) to retail stores. McNeil is offering two options for consumers who have purchased products affected by this recall. You can receive either a refund for the average retail price of the product or a coupon for a free replacement (s) when the product becomes available again. Click here to request a refund or product coupon. To process your refund or coupon you will need the NDC number and Lot number from the product that has been recalled. The NDC number can be found above the brand name on the label of the bottle. The Lot number can also be found on the label and is usually placed vertically on the label.

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Will you be offering a refund for the product I purchased and has been recalled?

Yes
McNeil is offering two options for consumers who have purchased products affected by this recall. You can receive either a refund for the average retail price of the product or a coupon for a free replacement (s) when the product becomes available again.
Click here to request a refund or product coupon. To process your refund or coupon you will need the NDC number and Lot number from the product that has been recalled. The NDC number can be found above the brand name on the label of the bottle. The Lot number can also be found on the label and is usually placed vertically on the label.

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What is this recall about?

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. If you are not sure about alternative pediatric health treatment options, you should talk to your child’s healthcare provider. Remember, you should never give drug products to infants and children that are not intended for those age groups as this could result in serious harm. For information on disposing of over-the-counter medications, please go to www.smarxtdisposal.net


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Have there been any reports of adverse events associated with this product recall?

This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, you should discontinue use of these products. If you have any health concerns, we recommend that you contact your child’s healthcare provider. Any adverse reactions may 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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What should I do if I have given this product to my child or infant?

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. If you have any health concerns, we recommend that you contact your child’s healthcare provider. Any adverse reactions may 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.

What should I do if I have the product in my home?

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. For information on disposing of over-the-counter medications, please go to www.smarxtdisposal.net. If you have any health concerns, we recommend that you contact your child’s healthcare provider. Any adverse reactions may 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.

Unless instructed otherwise, do not dispose of unused medicines by emptying them into your sink, toilet, or storm drain.

Some states may have regulations regarding pharmacy or community take-back programs in which they may receive and dispose of returned unused drugs for patients. It is recommended that a local pharmacy or local authority be contacted to determine if it participates in such programs.

In the event that medicines can not be disposed by take-back programs, place them in the household trash taking the following steps.

• Make sure that they are in an unrecognizable sealed container; ensuring that children, pets, and others do not have access to the contents of the container;
• Dispose of the container in household trash.