October 2024 FDA Recall Cisplatin by Accord Healthcare, Inc.
D-0010-2025 - Failed Impurities/Degradation Specifications.

This Class II drug recall was voluntarily initiated by Accord Healthcare, Inc. on October 1, 2024 for the product Cisplatin. The FDA reported the reason for recall as failed impurities/degradation specifications.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0010-2025

Reason for Recall
Failed Impurities/Degradation Specifications.
Initiated
10-01-2024
Reported
10-23-2024
Quantity
11,214 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95455
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ACCORD HEALTHCARE, INC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States and PR
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-23-2026
Product Description About Product Description
Full technical description of the product.
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

16729-288-11 Cisplatin
16729-288-38 Cisplatin