UPDATE TO APRIL 30, 2010 VOLUNTARY RECALL
May 14, 2010
Dear Healthcare Professional:
We would like to provide you with additional information about the voluntary McNeil Consumer Healthcare recall on pediatric liquids announced on April 30, 2010. We are receiving questions from healthcare professionals like you regarding this recall and would like to provide additional information that may be helpful to you and your patients. Attached is a Q&A addressing some common questions that we have received.
It is important for you and your patients to know that this recent recall was undertaken as a precaution because some of the medicines included in the recall may not have met required quality standards. The recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these medicines to their children.
As we previously communicated to you, some of the medicines 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. More details on these are provided below in the Q&A. While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use.
We have no higher concern than providing you and your patients with the highest quality medicines. The quality issues that have been identified are unacceptable to us, and not indicative of how McNeil Consumer Healthcare intends to operate. We apologize to you and your patients who rely on our medicines and we are committed to comprehensively remediating these issues and ensuring that our quality systems meet the high standards that you expect from us and that we expect from ourselves.
As always, we ask that you take the time to discuss the appropriate use of OTC medicines with your patients and remind them never to 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 websites for healthcare professionals at TylenolProfessional.com or ZyrtecProfessional.com. For more information on the recall, please visit mcneilproductrecall.com.
Sincerely,
