Teva Pharmaceuticals has initiated a voluntary recall of a single lot of Topotecan Injection to the retail/institutional level in the U.S., after a pharmacy observed a glass particle inside one of the vials.
The injection is used in the treatment of patients with metastatic ovarian cancer after disease progression and for patients with small cell lung cancer who progressed after chemotherapy.
After further examination of the complaint sample, two other particulates were found and identified as one grey silicone particle and one translucent, colorless cotton fiber. Teva had sent the affected batch to six wholesalers across the U.S. The drugmaker said it hadn’t received any side effect reports or additional particle complaints.
Syringe inspection has been a historically challenging endeavor for drugmakers. Read our recent Q&A about how new techniques and more versatile equipment can improve sterile injectable quality.