Generics juggernaut Sun Pharma is pulling one lot of a chemotherapy drug in the United States as the issue of particulate contamination crops up once again on the FDA’s recall register.
Sun’s voluntary recall concerns a single batch containing 675 vials of the chemotherapy doxorubicin hydrochloride liposome injection, which is used to treat ovarian cancer, Kaposi sarcoma and multiple myeloma, according to a notice posted on the FDA’s website.
The Mumbai-based company is yanking the batch after the discovery of “glass particles in some vials during production.”
Administering an intravenous drug that contains the particulates could have serious health consequences, though Sun noted in its May 13 recall notice that it hasn’t received any adverse event reports linked to the suspect lot.
Aside from the potential for local irritation and swelling from the presence of foreign material, intravenous injection of glass particles can, in more serious circumstances, block blood vessels and lead to life-threatening clotting, according to Sun’s release.
Sun did not provide details on the cause of its glass particle problem, though the company stressed that it has “thoroughly investigated the source” and taken “corrective and preventative actions” in response to the issue.
The doxorubicin vials in the affected batch were slated to expire at the end of next May.
Glass particles have prompted several recalls over the years, including in Oct. 2023, when Pfizer’s Hospira unit yanked certain sodium bicarbonate and lidocaine HCI injectables over the possible presence of minute bits of glass in product vials.
Earlier that same year, GSK recalled two batches of its asthma drug Nucala in Taiwan after glass particles were found in a vial of the drug. GSK had learned of the issue after receiving a complaint from a hospital in Taiwan about the presence of glass particles in one reconstituted vial of the medication.
Meanwhile, India’s Zydus in 2024 received an FDA warning letter at its Waghodia plant in Gujarat in part because the company failed to properly root out the source of cross-contamination incidents, including with glass particulates in batches of a product used to treat and prevent a lack of vitamin B12.