FDA Warns B&A for Noncompliant Ingredients in OTC Fever Drug

B&A Health Products has received an FDA warning letter for distributing an OTC liquid drug product with active ingredients that do not comply with the monograph for OTC cold, cough, allergy, bronchodilator and antiasthmatic drug products.

According to its package labeling, Pancold A is intended for use as a pain reliever, fever reducer, antihistamine, sputum suppressant, sneeze suppressant and nasal decongestant, but the product contains anhydrous caffeine and di-methylephedrine hydrochloride, which do not comply with the final monograph for OTC drugs of that type.

B&A was not aware the ingredients used in the drug are inappropriate and it is working on reformulating the product to stop using those ingredients, sales director Donald Han said.
Drug GMP Report