Sagent Pharmaceuticals: Drug Recall

Recall #D-0553-2024 · 05/28/2024

Class I: Dangerous

Recall Details

Recall Number: D-0553-2024
Classification: Class I
Product Type: Drug
Recalling Firm: Sagent Pharmaceuticals
Status: Ongoing
Date Initiated: 05/28/2024
Location: Schaumburg, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 762 vials

Reason for Recall

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

Product Description

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

Distribution Pattern

Nationwide within the USA.

Other Recalls by Sagent Pharmaceuticals

Class I: Dangerous 05/28/2024

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class II: Risk 04/25/2024

Presence of Particulate Matter: Potential for black particulates in the drug product.
Class II: Risk 07/11/2023

Lack of Assurance of Sterility
Class II: Risk 07/11/2023

Lack of Assurance of Sterility
Class II: Risk 07/11/2023

Lack of Assurance of Sterility

View all recalls by Sagent Pharmaceuticals →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.