Home / Recalls / Sagent Pharmaceuticals / D-0554-2024

D-0554-2024 Class I Ongoing

Recalled by Sagent Pharmaceuticals — Schaumburg, IL

Recall Details

Product Type
Drugs
Report Date
June 19, 2024
Initiation Date
May 28, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2806 vials

Product Description

Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08

Reason for Recall

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

Distribution Pattern

Nationwide within the USA.

Code Information

Lot #: F1030001, Exp. Date 12/31/2024

Other recalls by Sagent Pharmaceuticals

  • D-0553-2024 Class I — Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Via (May 28, 2024)
  • D-0499-2024 Class II — MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg p (April 25, 2024)
  • D-0937-2023 Class II — Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intr (July 11, 2023)
  • D-0935-2023 Class II — Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. f (July 11, 2023)
  • D-0936-2023 Class II — Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, label (July 11, 2023)
  • D-0763-2023 Class II — Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmace (May 19, 2023)
  • D-0764-2023 Class II — Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. f (May 19, 2023)
  • D-0762-2023 Class II — Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmace (May 19, 2023)
  • D-0435-2023 Class II — Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Via (February 28, 2023)
  • D-0305-2021 Class II — Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packag (March 11, 2021)