Drug Recall
April 30, 2010
Dear Healthcare Professional:
I am writing to inform you that McNeil Consumer
Healthcare, Division of McNEIL-PPC, Inc., in consultation with the U.S. Food
and Drug Administration (FDA), is voluntarily recalling certain
over-the-counter (OTC) Children’s and Infants’ liquid products. The company is
initiating this recall because some of these products may not meet required
quality standards. McNeil is providing the following information to consumers
on the www.mcneilproductrecall.com
web site.
McNeil Consumer Healthcare Announces Voluntary Recall
of Certain OTC Infants’ and Children’s Products
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.
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.
The company is conducting a comprehensive quality
assessment across its manufacturing operations and has identified corrective
actions that will be implemented before new manufacturing is initiated at the
plant where the recalled products were made.
Consumers can contact the company at 1-888-222-6036
and also at www.mcneilproductrecall.com.
Parents and caregivers who are not sure about alternative pediatric health
treatment options should talk to their doctor or pharmacist and are reminded to
never give drug products to infants and children that are not intended for
those age groups as this could result in serious harm.
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.Please note that the following pediatric samples
listed below are a part of this product recall. Please dispose of these
products immediately. For information on disposing of over-the-counter
medications, please go to
www.smarxtdisposal.net.
CONCENTRATED TYLENOL® INFANTS’ DROPS 1/4 OZ GRAPE
(NDC - 50580-144-40)
CHILDREN’S TYLENOL® SUSPENSION 1 OZ. CHERRY BLAST
FLAVOR (NDC -50580-123-01) CHILDREN’S MOTRIN® SUSPENSION 1 OZ.
GRAPE (NDC -50580-603-01)
CHILDREN’S MOTRIN® SUSPENSION 1 OZ.
BUBBLEGUM (NC -50580-604-01)
CHILDREN’S MOTRIN® SUSPENSION 1 OZ.
BERRY (NDC -50580-601-01)
CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE
0.5 OZ. GRAPE (NDC- 50580-730-15)
CHILDREN’S ZYRTEC® SUGAR-FREE
DYE-FREE 0.5 OZ.BUBBLEGUM (NDC - 50580-721-15)
Because of this recall, most of these products will
not be available for your patients to purchase for some time. We are committed
to bringing high quality products back to the marketplace. As always, we ask
that you take the time to discuss the appropriate use of OTC medicines with
your patients and remind them to never give drug products to infants and
children that are not intended for those age groups as this could result in
serious harm.If you have any questions yourself, please call our
Medical Affairs Department at 1-866-948-6883 (available Monday-Friday 8 a.m. to
8 p.m. Eastern Time) or visit our dedicated web sites for Healthcare
Professionals at TylenolProfessional.com or ZyrtecProfessional.com.
Sincerely,Edwin K. Kuffner, MD
Vice President, Medical Affairs
McNeil Consumer Healthcare
back |
