Batch of antibiotic for respiratory tract, skin infections to be recalled from market – FDA

MANILA, Philippines — A drug company is voluntarily recalling a batch of a locally manufactured antibiotic used for the treatment of respiratory tract infections, leprosy and other skin infections for failing laboratory tests, according to the Food and Drug Administration (FDA).

In an advisory, the FDA identified the drug product as Clarithrocid 250 mg/5 mL granules for suspension, with generic name Clarithromycin, manufactured by El Laboratories Inc. in Biñan, Laguna, and distributed by The Cathay Drug Company Inc.

The specific batch of the antibiotic being pulled out of the market has a lot number 150947 with an expiry date in September 2016.

“This is to inform the public that The Cathay Drug Company, Inc. is voluntarily recalling the impacted lot of Clarithrocid…due to the failure of the subject product in the assay test conducted by the FDA-Central Laboratory,” said the regulatory agency.

The drug is indicated for the treatment of infections in the respiratory tract, skin and soft tissue, leprosy, infections due to Mycobacterium avium, protozoal infection and for eradication of Helicobater pylori associated with peptic ulcer.

The FDA ordered all distributors, retailers, hospitals and pharmacies that have the affected lot of the antibiotic to immediately stop its distribution, sale and use.  “All consumers are likewise advised not to purchase or use the affected product lot,” it added.

All officers of the FDA’s Field Regulatory Operations Office were also instructed to monitor the presence of the product lot in the market, to appropriately seal the discovered stocks of the affected lot and to instruct the concerned establishments to return the sealed stocks to the distributor.

The FDA has said the sealed stocks will be destroyed in the presence of an appropriate FDA representative.  SFM