Class I

Drug Recall: 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

Sagent Pharmaceuticals · May 28, 2024

Reason for Recall

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

Distribution

Nationwide within the USA.

States Affected

NATIONWIDE

Quantity Affected

762 vials

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0553-2024

Status: ongoing

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