FDA Warns vs. Fake Variant of Clarithromycin (Klaricid) for Pediatric Suspension in Fruit Punch-flavor

The Food and Drug Administration (FDA) warned the public on Monday to be vigilant against the spread of counterfeit variant of Clarithromycin (Klaricid) 250 mg/15 ml granules for pediatric suspension in fruit punch-flavor.

In FDA Advisory 2015-076, Department of Health (DOH) Secretary Janette L. Garin, who is also functioning as FDA acting director general, said the fake product is manufactured by Abbott Laboratories Limited-Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, S16 4XE, UK.

In the same FDA advisory, the differences between the authentic and registered medicines and the counterfeit one have been specified.

FDA said the registered/authentic product label is in “blue” color while the fake one is in “magenta” color.

In the authentic Clarithromycin with blue label, the following can be seen:

Product manufacturer: PT Abbot Indonesia, Indonesia; Importer and Distributor: Abbot Laboratories-Philippines; and FDA Registration Number DRP-2199.

In the” majenta label” of the “counterfeit Clarithromycin” product, the following can be observed:

Manufacturer: Abbot Laboratories Limited-UK; No importer and distributor licensed by FDA Philippines; Lot details (Lot Numbers and Expiry Date are invalid); The registration number (printed on the label-DR-XY34229) is non-existent.

The text in the label is also different and there is no “caution” statement printed. The yellow ribbon to indicate the correct volume (70 ml) is absent.

Laboratory analysis of the counterfeit product revealed that it does not contain the active ingredient of Clarithromycin.

In the interest of protecting public health and safety, Secretary Garin said they have ordered for the seizure of the aforementioned unregistered products.

“Likewise, 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 area of jurisdiction,” Garin said.

She also advised all consumers to purchase only their medications from FDA-licensed establishments.

She also warned all drug establishments on the importation, distribution or sale of the counterfeit products as she mentioned there is corresponding sanctions and penalties stipulated under Republic Act No. 8203 (Special Law on Counterfeit Drugs).

She further reminded that drug products registered with the FDA Philippines bear in their labels information in English or in Filipino for all consumers to understand. (PNA) SCS/LSJ