Drugs tainted with bits of rubber, carbon and other undeclared materials have fueled several recalls in recent years. After a pharmacy's complaint about one vial, Teva Pharmaceutical is the latest to pull a batch.
Teva is recalling one lot of its cancer med 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 let customers know about the product pull June 18. It said it hadn’t received any side effect reports or additional particle complaints by the time 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, however, 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.
“While the health hazard risk could be severe if particulate matter is infused,” Teva’s internal investigation found the odds were “remote or unlikely” that patients would be exposed to the affected product, the FDA said.
Teva sent the batch, which was 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. The company didn’t immediately respond to Fierce Pharma’s request for comment.
On its own, topotecan injection can be used to treat metastatic ovarian cancer in patients whose disease worsens on or after first or subsequent rounds of chemotherapy, plus certain non-small cell lung cancer patients. The drug is also used in combination with the chemotherapy cisplatin to treat stage IV-B recurrent or persistent cervical cancer that doesn’t respond to therapy.
Teva’s not the only company to run into particle concerns with its drugs in recent years. At the start of the year, Fresenius Kabi yanked one lot of its pain med ketorolac tromethamine injection after particles appeared in reserve samples. That was Fresenius’ second ketorolac tromethamine recall in less than a year. Previously, the company withdrew 13 lots of the drug in May 2020 after particulates made of carbon, silicon, oxygen and polyamide turned up in eight vials.
Takeda’s rare disease med Natpara offers another cautionary tale. The company in September 2019 recalled all U.S. doses of the injected hypoparathyroidism drug on the small chance that rubber particles could shed into the drug’s injector. In April of this year, the company said it had “made progress” but “not yet reached a solution” on its Natpara particulate problems.