MANILA, Philippines – The Food and Drug Administration (FDA) has ordered Pfizer to pull out of the market batches of its Loviscol cough syrup that the agency said carried wrong declaration in its labels.
In an advisory, the FDA said that Pfizer should recall certain batches of “Carbocisteine (Loviscol) 50 mg/ml syrup (oral drops)” due to “incorrect concentration declaration of the claim reflected in the formulation for both the carton and the bottle labels.”
The agency asked stores selling the product “to discontinue selling the same and immediately return them to Pfizer for proper disposition.”
The FDA warned that the “continuous distribution of the said product presents health risk to the consuming sector of the public especially the children.”
Pfizer on its website describes Loviscol as “a mucolytic with Carbocisteine as its active ingredient. It acts by regulating and normalizing the viscosity of secretions from the mucus cells of the respiratory tract thus making cough more productive. It also treats swelling of the air passages.” – Rappler.com