McNeil OTC Drug RECALL information!
Message below was sent from NATIONAL NAPNAP (see below if you have not already received this email). This has a link to print the entire list of lot numbers to provide to your patients if they ask about the recall.
Most NAPNAP members have probably seen the news and are aware that McNeil Consumer Healthcare, in consultation with the FDA, issued a voluntary recall all lots (see list below) that have not yet expired of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured and distributed in the US (and distributed in several other countries.) “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.
NAPNAP has developed the below parent questions and answers to help our members talk to concerned parents about the recall.
How do I know if the product I have is one of the recalled lots?
The recalled lots are listed on the McNeil site (and listed below). Parents should be instructed to check the lot numbers of the medications in their home. The lot number is located on the label of the bottle, above the brand name. For your convenience, we suggest you print out the below list to keep in your practice setting for easy reference.
The medication bottle in our home is from one of the recalled lots - now what?
Parents should be instructed that they should not use any of the recalled products. They can contact McNeil Consumer Healthcare for instructions on a refund or replacement. at www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m. to 10 p.m and Saturday-Sunday 9 a.m. to 5 p.m. EST).
How can I dispose of the product safely?
Parents who do not want to return the product should be instructed on ways to safely dispose the product, reminding them not to discard in the garbage on any place a young child may find them. Most pharmacies will accept all prescription and non-prescription drugs, herbal products, vitamin and mineral supplements and throat lozenges.
I have a bottle from one of the recalled lots and have already given some to my child. Is he/she in danger?
Pediatric healthcare providers may be receiving calls from concerned parents, especially if their child has received some medication from a recalled lot. Parents should be reassured that the recall is not because of any reported adverse affects. However, parents concerns are real and additional information is needed. Encourage parents to share stories and report any potential adverse affects their child may have experienced to you. At this time, there are no specific follow up instructions for children who have received medication from the recalled lots. Health care providers should report all adverse reactions should 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 can I use for my child if she/he has a fever?
Parents should be instructed to use generic or alternate brand products. Parent can also be instructed to look for a non-recalled lot number, or an alternative form of the medication, such as a chewable tablet. .Remind parents to read the label carefully and to never give drug products to infants and children that are not intended for those age groups as this could result in serious harm.
How can I learn more about the recall?
Consumers can contact the company at 1-888-222-6036 and also at www.mcneilproductrecall.com. Several blogs and website have proliferated over the weekend about this recall. Encourage parents to carefully assess the source of the information and not to panic from unsubstantiated information that may be on the Internet.
For more information from McNeil Consumer Healthcare, including a complete list of the recalled medications and their lot numbers, go to http://www.mcneilproductrecall.com/page.jhtml?id=/include/new_recall.inc.
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