ACCORD HEALTHCARE, INC.: Drug Recall

Recall #D-0010-2025 · 10/01/2024

Class II: Risk

Recall Details

Recall Number: D-0010-2025
Classification: Class II
Product Type: Drug
Recalling Firm: ACCORD HEALTHCARE, INC.
Status: Ongoing
Date Initiated: 10/01/2024
Location: Raleigh, NC, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 11,214 vials

Reason for Recall

Failed Impurities/Degradation Specifications.

Product Description

Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad 382 213, India. Mfg. Lic. No.: G/28/1336, NDC 16729-288-38

Distribution Pattern

Nationwide within the United States and PR

Other Recalls by ACCORD HEALTHCARE, INC.

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Class II: Risk 06/20/2025

Subpotent Drug: Assay below the approved specification
Class II: Risk 06/20/2025

Subpotent Drug: Assay below the approved specification
Class II: Risk 06/20/2025

Subpotent Drug: Assay below the approved specification
Class II: Risk 06/20/2025

Subpotent Drug: Assay below the approved specification

View all recalls by ACCORD HEALTHCARE, INC. →

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.