FDA warns on fake antibiotics for kids; defective anti-TB drug recalled

MANILA, Philippines — The Food and Drug Administration (FDA) has warned the public about the presence in the market of a fake variant of an antibiotic for children and the recall of a batch of a defective drug for the treatment of pulmonary tuberculosis.

In an advisory, the regulatory body states Abbott Laboratories has confirmed that Clarithromycin (Klaricid) 250 mg/5 mL granules for pediatric suspension in fruit punch flavor manufactured in Berkshire, United Kingdom is counterfeit.

Abbott Laboratories is the market authorization holder of the registered product, according to the FDA.

The FDA and the pharmaceutical firm have noted that the color of the design of the fake antibiotic’s packaging is magenta while the original has a blue label design. The fake drug also carried a different font style and had poor printing quality.

The two parties also pointed out that the counterfeit antibiotic listed Abbott Laboratories Limited-UK as the manufacturer, which was not on the FDA’s list of registered importer and distributor. The fake drug also carried an invalid lot number and expiry date and a non-existent registration number.

Laboratory analysis of the counterfeit antibiotic also revealed that it did not contain the active ingredient clarithromycin, which is used to treat many different types of bacterial infections affecting the respiratory system and the skin.

“All healthcare professionals and the general public are hereby warned to be vigilant about the [said] counterfeit drug product. This poses potential danger or injury to the consuming public,” warned the FDA.

To protect public health and safety, the agency also ordered the seizure of the unregistered product found in the market. “All local government units and law enforcement agencies are requested to ensure that this product is not sold or offered for sale in their localities or areas of jurisdiction,” said the FDA.

In a separate bulletin, it has announced that some batches of Isoniazid (Isonid) 200mg/5mL syrup, manufactured by Concept Pharmaceuticals Ltd. in India, are being recalled from the market for failing to conform to the specifications of pH and physical appearance.

The product being pulled out has a registration number of DR-XY30788 with batch numbers C30002, C30003 and C30007. The affected batches have expiry dates of May 2016, May 2016, and July 2016, respectively.

“Syrup should remain physically stable under conditions of varying temperature (resistant to crystallization of precipitation). However, the samples tested were observed with white precipitates and with presence of crystals or precipitates around the cap,” noted the FDA.

The samples also ranged from yellow to dark yellow syrup, which did not conform to the correct color specifications of the syrup, which should be light yellow or clear and transparent, it added.

“The affected product batches present safety risks and potential adverse health consequences. Therefore, distributors, retailers, hospitals, pharmacies or clinics that have the affected batches are instructed to discontinue further distribution, sale and use,” said the FDA.  SFM