pharmacies have removed some over-the-counter infants’ and children’s medicines
from their shelves following a recall of 40 commonly used child medications.
include liquid Tylenol, Motrin, and Zyrtec.
This is the second time this year
that the manufacturer, McNeil Consumer Healthcare has launched a recall
involving Tylenol. In January, it recalled Tylenol and other over-the-counter
drugs because of a musty odour emanating from the products made in a Puerto
Officer of Health at the Cayman Islands Health Services Authority Kiran Kumar
said the list of recalled products had been passed on to the islands’ chief
pharmacist and had been circulated to all pharmacies.
McNeil Consumer Healthcare is
recalling all lots of certain liquid products manufactured in the US, at a
factory in Fort Washington, Pennsylvania. The Food and Drug Agency on Tuesday
released a scathing report slamming the conditions at the factory.
According to the FDA, McNeil did
not initiate “corrective and prevention action” after it had received
46 consumer complaints from June 2009 to April 2010 about foreign materials and
black or dark specks in its drugs.
The recalled batches have been
distributed in the US, Canada, Dominican Republic, Dubai in the United Arab
Emirates, Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad and Tobago,
and Kuwait. Much of Cayman’s pharmaceutical products are imported from the US.
Company officials said they were initiating
the voluntary recall because “some of these products may not meet required
quality standards”, but that no-one had suffered adverse medical reactions to
taking the drugs.
“However, as a precautionary
measure, parents and caregivers should not administer these products to their
children,” a statement released by McNeil said.
“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 carrying out a quality
assessment across its manufacturing operations and says it has identified
corrective actions that will be implemented before new manufacturing is
initiated at the plant where the recalled products were made.
Parents and caregivers who are not
sure about alternative paediatric 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
Parents who want to check if
medications they have in their homes are included in the list can enter the NDC
number that identifies each batch on www.mcneilproductrecall.com/page.jhtml?id=/include/mpr_ndc_finder.inc.
Product NDC numbers can be located
on the label of the bottle above the brand name.
a full list of the recalled products, visit www.fda.gov/Safety/Recalls/ucm210443.htm.