Drug Enforcement D-0010-2025

Failed Impurities/Degradation Specifications.

Status

Ongoing

Classification

Class II

Report Date

October 23, 2024

Termination Date

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Product Information

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
Product quantity
11,214 vials
Reason for recall
Failed Impurities/Degradation Specifications.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within the United States and PR

Location & Firm

Recalling firm
ACCORD HEALTHCARE, INC.
Address
8041 Arco Corporate Dr Ste 200

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0010-2025
Event ID
95455
Recall initiation date
October 1, 2024
Center classification date
October 11, 2024
Code info
Lot #: P2202009, Exp. Date: 03/2025
More code info
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