Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial recall — FDA D-0554-2024
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Overview of recall records associated with Sagent Pharmaceuticals, including dates, categories and classifications where available.
Classification mix: Class II: 3, Class I: 2.
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Presence of Particulate Matter: Potential for black particulates in the drug product.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
This page summarizes recall records in which the official source identifies Sagent Pharmaceuticals as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.