Generic drug giant Sun Pharma is recalling one lot of its chemotherapy drug in the United States as particulate contamination issues resurface in the FDA’s recall registry.
Sun’s voluntary recall concerns a single batch containing 675 vials of Doxorubicin Hydrochloride Liposomal Injection, a chemotherapy drug used to treat ovarian cancer, Kaposi’s sarcoma, and multiple myeloma, according to a notice posted on the FDA’s website.
The Mumbai-based company is recalling batches after “glass particles were found in some of the vials being manufactured.”
Intravenous administration of drugs containing the particles can have serious health effects, but Sun said in its May 13 recall notice that it had not received any reports of adverse events related to the suspect lot.
Aside from possible local inflammation and swelling due to the presence of a foreign body, intravenous injection of glass particles can block blood vessels and cause life-threatening clots in more serious situations, according to a Sun release.
Sun did not provide details about the cause of the glass particle problem, but stressed that the company had conducted a “thorough investigation into the source” and had taken “corrective and preventive actions” in response to the problem.
The doxorubicin vials from the affected batch were scheduled to expire at the end of May next year.
Glass particles have caused several recalls over the years, including in October 2023, when Pfizer’s Hospira division recalled certain sodium bicarbonate and lidocaine hydrochloride injections due to the possible presence of tiny glass particles in the product vials.
Earlier that year, GSK recalled two lots of its asthma drug Nucala in Taiwan after glass particles were found in vials of the drug. GSK learned of the issue after receiving a complaint from a Taiwanese hospital about the presence of glass particles in one reconstituted vial of the drug.
Meanwhile, India’s Zydus received a warning letter from the FDA at its Wagodia factory in Gujarat in 2024, in part because the company failed to adequately eradicate sources of cross-contamination incidents, such as glass particles in batches of a product used to treat and prevent vitamin B12 deficiency.
