A batch of a chemotherapy product made at a Sun facility with a history of quality and compliance issues is being withdrawn from the U.S. market.
Sun Pharma is recalling one batch of a chemotherapy drug from the U.S. after detecting glass particles in some of the vials.
The recall affects 675 vials of doxorubicin hydrochloride liposome, an intravenous chemotherapy drug used to treat AIDS-related Kaposi sarcoma, multiple myeloma and ovarian cancer. Sun is notifying its distributor and customers of the recall and arranging the return of affected products. Organizations with recalled vials should stop using the products and return them to their place of purchase.
Sun has not received any adverse event reports related to the batch, but there is potential for the glass particles to harm patients. Intravenous administration of the recalled drug could cause local irritation or swelling as patients react to the foreign material. Blood vessel blockages and life-threatening blood clots are also possible. Patients should contact their physician if they have problems linked to the drug.
The Indian drugmaker investigated the source of the problem and has “taken corrective and preventive actions,” but hasn’t shared further details yet. The product label states the vials were manufactured at a Sun facility in Halol, India.
That facility has a history of quality and compliance problems dating back more than 10 years. In 2014, FDA inspectors listed 19 pages of problems at the facility. The next year, the FDA sent a warning letter and rescinded the approval of Sun’s epilepsy drug Elepsia XR due to issues at the site.
The company received a Form 483 with nine observations after the FDA inspected the plant in 2016. The next year, the FDA rejected a request for approval of Elepsia XR based on inspection findings. Inspectors issued another Form 483 when they returned to the plant in 2018 but ultimately found Sun had resolved the problems raised in the warning letter.
However, the FDA sent another Form 483 in 2019. The next year, the FDA classified the facility as “official action indicated” (OAI). The status can precede a warning letter and rejections for drugs made at the affected facility.
An FDA inspection performed in 2022 triggered another warning letter. Inspectors found fault with Sun’s vial-filling equipment, which they said caused friction that introduced “blackish fine metallic particles.” The FDA imposed an import alert on products made at the facility. Inspectors visited the site again last year, leading to a Form 483 in June. In September, the FDA again classified the facility as OAI.
