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June 30, 2021Teva Recalls Topotecan Injection to Retail/Institutional Level
June 30, 2021 – Teva Pharmaceuticals has recalled one lot of Topotecan Injection 4mg/4mL (1mg/mL) to the retail/institutional level after receiving a complaint from a pharmacy. Examination of the complaint sample found glass, silicone, and cotton fiber particulates in the product.
Administering an injectable product that contains particulate matter can have consequences ranging from localized irritation or swelling to fatal blood vessel blockages. Topotecan injection is indicated to treat certain patients diagnosed with small cell lung cancer or cervical cancer.
According to Teva, the likelihood of patient exposure to the affected product is remote or unlikely. The company distributed the affected product to six wholesalers nationwide, which have all been notified and advised to return the recalled topotecan. Teva had received no additional complaints or reports of illness or injury as of the date of the recall.
Teva advises consumers who have questions or concerns to first consult their healthcare provider. For medical-related questions or to report adverse events or quality complaints, consumers can contact Teva Medical Information at 1-888-838-2872 (option 3, then option 4) or druginfo@tevapharm.com. Adverse events can also be reported to the U.S. FDA’s MedWatch program.
A full copy of the recall announcement is available on the FDA’s website.
There is no impact to members through Benecard Central Fill.