Children's Cough Medicine Sold at Kroger, CVS, Rite-Aid, Dollar General, Other Stores Recalled Amid Overdose Concerns
January 12, 2016 - 7:49 PM
(Photo Provided by Perrigo)
DUBLIN - Perrigo Company announced today that,
following the recent recall of certain dosing cups by its supplier, it
has initiated a voluntary product recall in the US to the retail level
of 2 batches of its children's guaifenesin grape liquid (100mg/5 mL) and
3 batches of its children's guaifenesin DM cherry liquid (100mg
guaifenesin and 5mg dextromethorphan HBr/ 5 ml) sold in 4 oz. bottles
with dosage cup in a box under the store brand products listed below.
This recall is being initiated because some packages contain an oral
dosing cup with incorrect dose markings.
Use of these products according to labeled instructions with an
affected dosing cup is unlikely to result in serious side effects, and
no reports related to overdose have been received to date. Consumers
should be aware that an overdose of Guaifenesin DM may cause hyper
excitability, rapid eye movements, changes in muscle reflexes, ataxia,
dystonia, hallucinations, stupor, and coma. Other effects have included
nausea, vomiting, tachycardia, irregular heartbeat, seizures,
respiratory depression, and death. Gastric decontamination is
recommended after acute ingestion of greater than 10 mg/kg, if
administered soon after ingestion. At risk populations such as those who
are poor metabolizers of dextromethorphan may experience an overdose by
a factor of 3, if incorrect measuring levels are used. Additionally,
small children who are poor metabolizers of dextromethorphan and use the
product regularly over a period of several days at the mistaken dose,
may develop cumulative toxicity. Moreover, adverse reactions to
guaifenesin when given in high or excessive dosage may include
nausea/vomiting, diarrhea, and/or abdominal pain. Therefore, an extreme
overdose in an at risk population may need medical intervention, but in
most cases adverse health consequences are temporary and reversible.
Commenting on this market action, Perrigo's Chairman and CEO Joseph C. Papa
stated, "There have been no reports of adverse events to Perrigo as a
result of the incorrect dosage markings. Perrigo is taking this action
to maintain the highest possible product quality standards for our
retail customers and consumers. We are taking this action because it is
the right thing to do."
These OTC products are indicated for helping loosen phlegm (mucus)
and thin bronchial secretions and making coughs more productive, as well
as in the case of the DM product to temporarily relieve: coughs due to
minor throat irritations, the intensity of coughing, and the impulse to
cough. 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, followed by formal FedEx-delivered communication.
It also is arranging for return of all recalled products.
Distributors/retailers that have the affected batches of children's
guaifenesin grape liquid and/or children's guaifenesin DM cherry that is
being recalled should stop distribution and return product.
Consumers that have product with the corresponding labels and batch
numbers listed below should discard the dosing device and product and
may call Perrigo, toll free, Monday through Friday from 8:00 AM to 10:00 PM EST,
at 1-888-345-0479, or visit mucusreliefrecall.com. Consumers should
contact their physician or healthcare provider if they have any
questions, or if they or their children experience any problem that
could possibly be related to this drug product.
Adverse reactions or quality problems experienced with the use of
this product may be reported to the FDA's MedWatch Adverse Event
Reporting program either online, by regular mail or by fax.