Product Safety Recalls

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CISPLATIN Recall D-0010-2025

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

CISPLATIN Recall D-0010-2025 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0010-2025
Event ID95455
BrandCISPLATIN
Generic NameCISPLATIN
ManufacturerCISPLATIN
Original Package?1
Active SubstanceCISPLATIN
Drug RouteINTRAVENOUS
DistributionNationwide within the United States and PR
Quantity11,214 vials
Recall ReasonFailed Impurities/Degradation Specifications.
Drug ClassificationClass II
Drug Code Info20241023
Product NDC16729-288
Product NUIN0000175413 N0000175073
Pharma Class (EPC)Platinum-based Drug [EPC]
Recall Initiation Date20241001
Report Date20241023
Classification Date20241011
Address8041 Arco Corporate Dr Ste 200
Raleigh, NC 27617-2010
United States
Recalling FirmACCORD HEALTHCARE, INC.
Initial Notification Letter
Unique Ingredient IdentifierQ20Q21Q62J
Drug Application NumberANDA206774
Structured Product Labeling (SPL ID)c43de769-d6d8-3bb9-e053-2995a90a5aa2
Structured Product Labeling (SPL Set ID)b2b029f5-0d7e-4e7f-accc-b722aec34c68
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