PERRIGO INITIATES NATIONWIDE VOLUNTARY PRODUCT RECALL OF
ACETAMINOPHEN INFANT SUSPENSION LIQUID, 160 mg/5 mL, DUE TO A POTENTIAL
DEFECT WITH THE CO-PACKAGED ORAL SYRINGE
The
Perrigo Company (NYSE:
PRGO; TASE) announced today that it has initiated a voluntary,
nationwide product recall to the retail level of 18 batches of its
acetaminophen infant suspension liquid, 160 mg/5 mL, sold in 2 oz. and 4
oz. bottles with syringes in a box under the store brand products
listed below. The recall is being initiated because of the remote
potential that a small number of packages might contain an oral dosing
syringe without dose markings. The correct syringe should have a white
or yellow plunger with specific dose markings for 1.25 ml, 2.5 mL, 3.75
mL, and 5 ml. If the product's syringe has these dose markings,
consumers can continue to
use the product while following labeled use instructions.
Using an
oral syringe without dose markings can result in inaccurate
dosing, especially in infants who could mistakenly get too high a dose.
Commenting on this market action, Perrigo's Chairman, President
and CEO Joseph C. Papa stated, "There are no issues or concerns with
respect to the safety or efficacy of the product, only the potential
that the oral dosing device in a relatively small number of packages
could be unmarked. Out of an abundance of caution, we are taking this
measure to maintain the highest possible product quality standards for
our retail customers and consumers. While we cannot be certain that any
of these unmarked dosing devices were released into our customers'
supply chains, taking this action is the right thing to do." Perrigo has
not received any reports or complaints related to this defect nor have
they found any product with missing dose markings on re-examination of
product on hand.
This OTC product is indicated for the relief of fever and minor
aches and pains and can be used in infants, children and adults. These
recalled products are sold by distributors Nationwide and distributed
through retail stores.
Perrigo is notifying its distributors and customers by verbal and
e-mail communication today, followed by formal Fed Ex-delivered
communication. It also is arranging for return of all recalled products.
Distributors/retailers that have the
acetaminophen infant suspension liquid that is being recalled should stop distribution and return product.
If the oral dosing device contained in the package has dose
markings, no action is required, and the consumer can continue to use
the product consistent with the label instructions. If the package
contains an oral dosing device
that does not have dose markings,
the consumer should not use the product and should call Perrigo's
Consumer Affairs Department, toll free, 1-800-719-9260. Consumers should
contact their physician or health care provider if they have any
questions, or if they or their children experience any problem that
could possibly be related to this drug product.
If you or someone you know has been
injured due to a
defect product call the experienced product liability attorneys at Buttafuoco & Associates 1-800-669-4878
