Manila, Philippines - The Food and Drug Administration (FDA) has ordered Pfizer Consumer Healthcare to pull out from the market some batches of a cough syrup due to incorrect declaration of concentration.
In an advisory, FDA officer-in-charge Nick Lutero III said Pfizer should recall certain lots of Carbocisteine (Loviscol) 50 mg/ml syrup (oral drops) because of incorrect concentration declaration of the claim reflected in the formulation for both the carton and the bottle labels.”
“Continuous distribution of the said product presents health risk to the consuming sector of the public, especially the children,” he said.
“Any establishment carrying the... lots of the products are advised to discontinue selling the same and immediately return them to Pfizer for proper disposition.”
The Pfizer website describes Carbocisteine (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,” the website said. “It also treats swelling of the air passages.”