Home / Recalls / Sagent Pharmaceuticals / D-0937-2023

D-0937-2023 Class II Ongoing

Recalled by Sagent Pharmaceuticals — Schaumburg, IL

Recall Details

Product Type
Drugs
Report Date
August 2, 2023
Initiation Date
July 11, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
760 bottles

Product Description

Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide in the USA

Code Information

Lot: a) OXT202, exp 5/31/2025; OXT203, exp 5/31/2025; OXT301, exp 12/31/2025; b) OXT205, exp 6/30/2025; OXT204, exp 5/31/2025

Other recalls by Sagent Pharmaceuticals

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  • 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-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)