Batch of antibiotic for tumor to be withdrawn from market—FDA

MANILA, Philippines—A pharmaceutical firm is set to voluntarily recall a batch of anti-tumor antibiotic from the market, expressing doubts that the product manufacturer complied with Good Manufacturing Practice (GMP), according to the Food and Drug Administration (FDA).

In an advisory, the FDA said Merck Sharp and Dohme (I.A.) Corporation, a Philippine subsidiary of Merck & Co., Inc., has notified the agency about its intent to pull out Doxorubicin Hydrochloride 2mg/mL (20 mg/10mL) Pegylated Liposomal Concentrate for IV Infusion (Caspria) with lot number JKN0969B.

The pharmaceutical company told the FDA that the recall was “due to lack of assurance of compliance with current GMP” by manufacturer Sun Pharmaceutical Industries, Ltd. based in Panchamahal, Gujarat, India.

GMP are the practices necessary to conform to guidelines recommended by the FDA or other regulating and licensing bodies for the manufacture and sale of food, drug and pharmaceutical products to ensure that these products are safe for the public and are of high quality.

“The affected product presents safety risk and potential health consequences,” said the FDA acting director general, Dr. Kenneth Hartigan-Go.

Go instructed all distributors, retailers, hospitals, pharmacies and clinics that have the affected lot of the drug product to cease further distribution, sale and use. Consumers have also been warned against purchasing or using the affected products.

Doxurubicin Hydrochloride is used in association with other anti-neoplastic agents in the treatment of acute leukemia, lymphoma, sarcoma and other range of tumors. The product is packed in 10 mL glass vials, according to the FDA.

All field Food and Drug Regulation officers have also been directed to monitor the availability of the product batches in the market, added the FDA official.

He also encouraged consumers to contact the pharmaceutical firm at telephone number (02) 784-9500 or email the FDA at [email protected] for any inquiries or additional information about the recall.

“Any adverse reaction experienced from the use of the aforementioned product batches should be reported immediately to FDA by visiting www.fda.gov.ph,” added Go.