FDA warns vs fake antibiotic for kids, recalls TB drug

THE FOOD and Drug Administration (FDA) has warned the public about a fake variant of an antibiotic for children, even as it recalled batches of a drug for the treatment of pulmonary tuberculosis.

In an advisory, the FDA said Abbott Laboratories confirmed that the Clarithromycin (Klaricid) 250 mg/5 mL granules for pediatric suspension in fruit punch flavor manufactured in Berkshire, England, were counterfeit.

The FDA and Abbott noted the magenta color of the fake antibiotic’s packaging, while the genuine package had a blue label. The fake drug also had a different font and poor quality printing.

They said the counterfeit antibiotic listed Abbott Laboratories Ltd.-UK as the manufacturer, which is not on the FDA’s list of registered importers and distributors. The fake drug also had an invalid lot number and expiry date and a false registration number.

In a separate bulletin, the FDA said some batches of Isoniazid (Isonid) 200mg/5mL syrup manufactured by Concept Pharmaceuticals Ltd. of India were being recalled for failing to conform with pH and physical appearance specifications.

The pulled product had registration number DR-XY30788 with batch numbers C30002, C30003 and C30007. The batches have expiry dates of May 2016 and July 2016.

“The syrup should remain physically stable under conditions of varying temperatures (resistant to crystallization of precipitation). The samples tested, however, were observed to have white precipitates and crystals or precipitates around the cap,” the FDA said.

The samples ranged from yellow to dark yellow in color, which did not conform to the correct color specifications of the syrup, which should be light yellow or clear and transparent, it said. Jocelyn R. Uy