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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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.


GUAIFENESIN GRAPE LIQ 4 OZ

Label

Lot number

Expiry

H.E.B

5LK0592

08/2017

CVS

5MK0340

08/2017

 

GUAIFENESIN DM CHRY LIQ 4 OZ

Label

Lot number

Expiry

Sunmark

5LK0528, 5LK0630

03/2017

Rite-Aid

5LK0528, 5LK0630

03/2017

Topcare

5LK0528, 5LK0630, 5LK0779

03/2017

Kroger

5LK0528, 5LK0630

03/2017

GoodSense

5LK0528

03/2017

Dollar General

5LK0630

03/2017

Care One

5LK0630

03/2017

CVS

5LK0630

03/2017

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