Antitumor drug recalled
MANILA, Philippines–A pharmaceutical company has recalled a batch of antitumor antibiotics from the market, saying it doubted the product’s India-based manufacturer had complied with good manufacturing practice (GMP).
In an advisory to the Food and Drug Administration (FDA), Merck Sharp and Dohme (I.A.) Corp., the Philippine subsidiary of Merck & Co., notified the agency about its intention to pull out Doxorubicin Hydrochloride 2mg/mL (20 mg/10mL) pegylated liposomal concentrate for IV infusion (Caspria) with lot number JKN0969B.
The company told the FDA the recall was “due to lack of assurance of compliance with current GMP” by the manufacturer, Sun Pharmaceutical Industries, based in Panchamahal, Gujarat, India.
GMP is a prescribed system of practices to be followed in the manufacture of food, drug and pharmaceutical products to ensure that these products are safe for the public and are of high quality. It is recommended by the FDA and other regulating and licensing bodies in order to minimize the risks involved in any product particularly pharmaceuticals, that cannot be eliminated through testing the final product.
“The affected product presents safety risk and potential health consequences,” said FDA Acting Director General Dr. Kenneth Hartigan-Go.
Doxurubicin Hydrochloride is used in association with other antineoplastic agents in the treatment of acute leukemia, lymphoma, sarcoma and other ranges of tumors. The product comes packed in 10 mL glass vials, the FDA said.
Go urged consumers to contact Merck Sharp and Dohme at tel. 7849500 or e-mail the FDA at [email protected] for inquiries or 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,” Go said.