Home / Recalls / Sagent Pharmaceuticals / D-0499-2024

D-0499-2024 Class II Ongoing

Recalled by Sagent Pharmaceuticals — Schaumburg, IL

Recall Details

Product Type: Drugs
Report Date: May 22, 2024
Initiation Date: April 25, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 14,360 vials

Product Description

MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10

Reason for Recall

Presence of Particulate Matter: Potential for black particulates in the drug product.

Distribution Pattern

Nationwide in the USA

Code Information

Lots 5100186, 5100187, 5100188, 5100189, Exp 01/31/2025

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-0554-2024 Class I — Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose (May 28, 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-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-0763-2023 Class II — Nafcillin for Injection, USP, 2 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)