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Officials with Perrigo Company have announced that, following the recent recall of certain dosing cups by its supplier, they have initiated a voluntary product recall of 2 batches of 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. The recall is being initiated because some packages contain an oral dosing cup with incorrect dose markings.
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.
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. The affected lots for Guaifenesin grape Liquid are Lot # 5LK0592 and 5MK0340 with expiration dates of 08/2017. The affected lots for Guaifenesin DM Cherry Liquid are Lot # 5LK0528, 5LK0630, and 5LK0779 with expiration dates of 03/2017.
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.
Use of these products according to labeled instructions with an affected dosing cup is unlikely to result in serious adverse events, and no reports related to overdose have been received to date.
