Cisplatin Injection
FDA Recall NDC 16729-288
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Cisplatin (NDC 16729-288). A significant event, classified as Class II, was initiated on Oct 01, 2024 by Accord Healthcare Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
October 2024 Class II Recall: Failed Impurities/Degradation Specifications.
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications.
Oct 01, 2024
Oct 23, 2024
11,214 vials
Recall Profile & Regulatory Data
Event ID
95455
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
ACCORD HEALTHCARE, INC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States and PR
Termination Date
Feb 23, 2026
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
Batch or Lot Expiration Information
Lot# : P2202009, Exp. Date: 03/2025
Affected Packages Involved in this Recall
16729-288-11Product
16729-288-38Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
