Incorrect Dosing Cup Results in Recall of Children's Cough SyrupsJan 21, 2016
Perrigo Company of Dublin, Ireland, has recalled five batches of children's cough syrups because some of the packages contain an oral dosing cup with incorrect dose markings. Children taking the medicine could receive an overdose.
Included in the recall are two batches of guaifenesin grape liquid (100mg/5 mL) and three batches of guaifenesin DM cherry liquid (100mg guaifenesin and 5mg dextromethorphan HBr/ 5 ml) sold in 4 oz. bottles with a dosage cup included in the box. Perrigo produces the medicines under a number of store brands, including CVS, H.E.B., Sunmark, Rite Aid, Kroger, Good Sense, Dollar General, and Care One. The recalled products are sold nationwide through retail stores.
A list of lot numbers and expiration dates for the recalled cough syrups can be found on the Food and Drug Administration (FDA) web site.
The FDA says that use of the incorrectly marked dosing cup is unlikely to result in serious side effects, but guaifenesin DM overdose may cause hyper excitability, rapid eye movements, changes in muscle reflexes, ataxia (loss of control of body movements), dystonia (muscle spasms), hallucinations, stupor, and coma. The child may also experience nausea, vomiting, rapid or irregular heartbeat, seizures, depressed respiration, and death. Gastric decontamination is recommended after ingestion of greater than 10 mg/kg, if treatment is administered soon after ingestion.
Children who are poor metabolizers of dextromethorphan may experience an overdose by a factor of three if incorrect measuring levels are used. Small children who are poor metabolizers of dextromethorphan and are given an incorrect dose of the cough syrup over a period of several days may develop cumulative toxicity. Adverse reactions to guaifenesin when given in high or excessive dosage may include nausea and vomiting, diarrhea, and abdominal pain. An extreme overdose in an at-risk population may need medical intervention, but in most cases adverse health consequences are temporary and reversible.
These over-the-counter (OTC) cough syrups are used to help loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive. The DM product helps to temporarily relieve coughing due to minor throat irritations, and eases the intensity of coughing, and the impulse to cough.
Perrigo is notifying distributors and customers by phone and e-mail, followed by a formal communication delivered through FedEx. The firm is arranging for return of all recalled cough syrups. Distributors and 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 who have the recalled cough medicines on hand should discard the dosing cup and call Perrigo, toll free, Monday through Friday from 8:00 AM to 10:00 PM EST, at 1-888-345-0479, or visit mucusrelief.com for further information. Perrigo advises consumers to contact the child's doctor if the child experiences any problem that could be related to the cough syrup.