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Potential overdose risk prompts U.S. recall of children’s guaifenesin

Perrigo Company, after conferring with the FDA, has issued a voluntary recall of two batches of children’s guaifenesin grape liquid and three batches of children’s guaifenesin DM cherry liquid due to incorrect dosing markings on the dosage cups.

The most common adverse effects reported with a guaifenesin DM overdose include hyper-excitability, rapid eye movements, ataxia, dystonia, hallucinations and stupor.

In addition, physicians and consumers should be aware of other potential effects such as nausea, vomiting, diarrhea, tachycardia, irregular heartbeat, seizures, respiratory depression, coma and death.

The manufacturer noted that gastric decontamination is recommended after acute ingestion of guaifenesin greater than 10 mg/kg, if administered soon after ingestion. At-risk populations, including those who are poor metabolizers of dextromethorphan, may experience an overdose by a factor of 3, if incorrect measuring levels are used.

In addition, small children who are poor metabolizers of dextromethorphan and use the product regularly over several days at the mistaken dose, could develop cumulative toxicity.

“There have been no reports of adverse events to Perrigo as a result of the incorrect dosage markings,” Joseph C. Papa, Perrigo chairman and CEO, said in a press release. “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.” 

The recalled medications include the following labels, lot numbers, and expiration dates:

Guaifenesin DM Cherry Liquid 4 Oz

Label                 Lot number                                         Expiration
Sunmark         5LK0528, 5LK0630                                3/1/2017
Rite-Aid          5LK0528, 5LK0630                                 3/1/2017
Topcare           5LK0528, 5LK0630, 5LK0779               3/1/2017
Kroger             5LK0528, 5LK0630                                3/1/2017
GoodSense      5LK0528                                               3/1/2017
Dollar General 5LK0630                                                3/1/2017
Care One        5LK0630                                                3/1/2017
CVS                 5LK0630                                               3/1/2017

Guaifenesin Grape Liquid 4 Oz

Label    Lot number      Expiration
H.E.B   5LK0592         8/1/2017
CVS     5MK0340        8/1/2017