Perrigo Company of Dublin, Ireland, announced that, following the recent recall of certain dosing cups by its supplier, it has recalled two batches of its children's guaifenesin grape liquid (100mg/5 mL) and three 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 the store brand products listed below. This recall is being initiated because some packages contain an oral dosing cup with incorrect dose markings.
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. At risk populations such as those who are poor metabolizers of dextromethorphan may experience an overdose by a factor of three, 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.
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.
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.
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. The recalled products are sold by distributors nationwide and distributed through retail stores.
The recalled lots were distributed under the following store labels. Recalled Guaifenesin Grape Liquid 4 ounce bottles were distributed under the store labels H.E.B. (Lot 5LK0592) and CVS (Lot 5MK0340). Recalled Guaifenesin DM Cherry Liquid 4 ounce bottles were distributed under the store labels Sunmark (Lots 5LK0528, 5LK0630), Rite-Aid (Lots 5LK0528, 5LK0630), Topcare (Lots 5LK0528, 5LK0630, 5LK0779), Kroger (Lots 5LK0528, 5LK0630), GoodSense (Lot 5LK0528), Dollar General (Lot 5LK0630), Care One (Lot 5LK0630), and CVS (Lot 5LK0630).
See the Recall
See the FDA Safety Alert
See also Medical Law Perspectives, August 2015 Report: Pediatrician Liability Involving Diseases and Conditions of Childhood
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication