Pfizer is voluntarily recalling its cough syrup medicine, Robitussin DM product, due to errors in its labeling, according to the Food and Drug Administration. Robitussin DM product contains Dextromethorphan HBr 15mg and Guaifenessin 100mg per 5ml.
FDA officer-in-charge and assistant secretary of health Nicolas Lutero III said the continuous distribution of the said product present health risk to the consuming sector of the public. “Anyone who may have bought the affected products are advised to discontinue using the same and immediately coordinate with Pfizer,” Lutero added.
The label indicated one teaspoonful or 2.5 ml for children between two and six years old when the correct dosage should be only half a teaspoon for every six hours, according to FDA officials. The FDA posted an online advisory (PDF) concerning the Robitussin recall on its website.
Prescription drug labeling errors are a dangerous problem. A July 2006 IOM report found that major problems with naming labeling and packaging cause of 33% of medication errors, including 30% of fatalities due to medication errors.
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