FDAClass IIOctober 23, 2024

Cisplatin Injection recall: Impurity Out of Spec

Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare Inc., Durham…

Why was Cisplatin Injection recalled?

Failed Impurities/Degradation Specifications.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: P2202009, Exp. Date: 03/2025

Product
Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare Inc., Durham…
Recalling firm
ACCORD HEALTHCARE, INC.
Quantity
11,214 vials
Distribution
Nationwide within the United States and PR
Recall date
October 23, 2024
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls