Recalls / Class II
Class IID-0010-2025
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
- Brand name
- Cisplatin
- Generic name
- Cisplatin
- Active ingredient
- Cisplatin
- Route
- Intravenous
- NDC
- 16729-288
- FDA application
- ANDA206774
- Affected lot / code info
- Lot #: P2202009, Exp. Date: 03/2025
Why it was recalled
Failed Impurities/Degradation Specifications.
Recalling firm
- Firm
- ACCORD HEALTHCARE, INC.
- Manufacturer
- Accord Healthcare Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8041 Arco Corporate Dr Ste 200, Raleigh, North Carolina 27617-2010
Distribution
- Quantity
- 11,214 vials
- Distribution pattern
- Nationwide within the United States and PR
Timeline
- Recall initiated
- 2024-10-01
- FDA classified
- 2024-10-11
- Posted by FDA
- 2024-10-23
- Terminated
- 2026-02-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0010-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.