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Taxotere Recall Issued in U.K. Due to Potency Error

Taxotere Recall Issued in U.K. Due to Potency Error

April 21, 2016 — The chemotherapy drug Taxotere has been recalled in the United Kingdom because a manufacturing error may have increased the potency of a small number of batches.

Sanofi-Aventis blamed the problem on a software failure during production. It may have allowed some ethanol (alcohol) to evaporate, which would increase the concentration of Taxotere in each dose. The company estimates that 0.09% of the 4 ml presentation could be affected.

Description of recalled Taxotere:

  • Taxotere (Docetaxel) Concentrate for Solution for Infusion, 80mg per 4ml EU/1/95/002/004 — Batch #5F219A — Expiration Date 31 August 2018.

In March 2001, Taxotere was recalled in the United States because the active drug in 20-mg vials may have accidentally been labeled as a “diluent” vial. The recall was issued after one complaint about mislabeling, which drug-makers believe is an isolated event.

This is not the first time Taxotere side effects have raised concerns. Last year, the FDA updated the label to include warnings about permanent alopecia (hair loss). The drug-maker is now facing lawsuits from women who say they were not adequately warned about the risk.

In June 2014, the FDA issued a warning about the risk of alcohol intoxication from infusions of Taxotere during chemotherapy. The FDA warns that patients may “feel drunk during and after treatment.” The agency has recommends slowing the infusion rate to help relieve symptoms. According to the FDA:

“Patients should avoid driving, operating machinery, or performing other activities that are dangerous for one to two hours after the infusion of docetaxel. In addition, some medications, such as pain relievers and sleep aids, may interact with the alcohol in the docetaxel infusion and worsen the intoxicating effects.”

Do I have a Taxotere Lawsuit?

The Schmidt Firm, PLLC is currently accepting Taxotere induced injury cases in all 50 states. If you or somebody you know has been diagnosed with permanent hair loss, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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