Perrigo initiates voluntary product recall in the US of children's guaifenesin grape liquid and guaifenesin DM cherry liquid

Recall due to a potential defect with the dosage cup.

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.