Teva Recalls Product Due to Particulate Matter

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The company is recalling one lot of Topotecan Injection 4 mg/4 mL (1 mg/mL) after a glass particle was found in a vial.

Teva Pharmaceuticals announced on June 30, 2021, that it has voluntarily recalled one lot of Topotecan Injection 4 mg/4 mL (1 mg/mL) because of a complaint of a single glass particle found inside one vial. The company examined the complaint sample and found one grey silicone particle and one translucent, colorless cotton fiber.The effected lot, 31328962B, was distributed to six of Teva’s wholesale distributors, has an expiration date of 04/2022, and is packaged in 4 mg/4 mL single-use vials. Customers were notified about the recalled product on June 18, 2021, and instructed to return the impacted product.

According to the company, particulate matter in an injectable product may result in local irritation or swelling if administered. Particulate matter can cause stroke or death if it reaches the blood vessels and travels to organs or blocks vessels in the heart, lungs, or brain. At the time of the recall announcement, Teva had not received any additional complaints or reports of illness or injury.


Source: FDA