Drug & medication recalls Moderate risk

Sanofi-Aventis U.S. LLC recalls Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., ND…

Recall date
April 27, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0804-2018
FDA classification
Class II
Brand / firm
Sanofi-Aventis U.S. LLC
Sold / distributed
US nationwide

Why it was recalled

Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC 0955-1020-01

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