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Sagent Pharmaceuticals recalls Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceutic

Recalled June 19, 2024 · FDA recall D-0553-2024 · Sagent Pharmaceuticals

Hazard
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product. · FDA Class I
Units
762 vials
Sold at
Nationwide within the USA.

Description

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.

Product
Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08
Manufacturer(s)
Sagent Pharmaceuticals

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov