Children’s Guaifenesin Grape Liquid and Guaifenesin DM Cherry Liquid, by Perrigo Company, Recalled due to Potential Defect with Dosage Cup
As the FDA announced, Perrigo Company following the recent recall of certain dosing cups by its supplier, is recalling 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 multiple store brand product names, as some packages contain an oral dosing cup with incorrect dose markings.
FDA Alert on Children’s Guaifenesin Grape Liquid and Guaifenesin DM Cherry Liquid, by Perrigo Company
According to the announcement “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.
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. 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.”
FDA Recommendation on Children’s Guaifenesin Grape Liquid and Guaifenesin DM Cherry Liquid, by Perrigo Company
“Gastric decontamination is recommended after acute ingestion of greater than 10 mg/kg, if administered soon after ingestion.
Consumers that have product with the corresponding labels and batch numbers listed in the Press Release 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.”
Contacting the FDA to report cases with Children’s Guaifenesin Grape Liquid and Guaifenesin DM Cherry Liquid, by Perrigo Company
In case of detection of adverse events or side effects related to the use of Children’s Guaifenesin Grape Liquid and Guaifenesin DM Cherry Liquid, by Perrigo Company, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:
- The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm
- The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form
- The completed form can be faxed to: 1-800-FDA-0178
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