Teva Recalls One Batch Of Topotecan After Complaint Of Glass Particulate In Vial

Teva Pharmaceutical Industries Ltd TEVA is recalling one lot of its cancer drug topotecan injection after a pharmacy complaint flagged the presence of a single glass particulate in a vial of the drug.
A follow-up review of the suspect sample turned up two other particles, which have been identified as grey silicone and “translucent, colorless cotton fiber,” a notice on the FDA’s website said.
Teva notified its customers on June 18 and asked that the lot be recalled. It said it hadn’t received any side effect reports or additional particle complaints when it announced the recall on June 30.
Injecting a drug that’s polluted with particulates can cause mild reactions such as injection-site irritation or swelling.
If particulates reach the blood vessels, they can make their way to the organs and block blood vessels in the heart, lungs, or brain, potentially leading to stroke or even death, the FDA said.
Teva sent the batch due to expire April 2022 to six wholesalers across the U.S.
The drug is packaged in 4 mg/4 mL single-use vials. Teva didn’t say how many vials were in the recalled lot.
Price Action: TEVA shares are down 1.46% at $9.77 during the market session on the last check Friday.