Why it was recalled
Failed Impurities/Degradation Specifications.
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
Lot numbers, UPCs & expiration codes
Lot #: P2202009, Exp. Date: 03/2025
Where it was sold
Nationwide within the United States and PR
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0010-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 1, 2024
- FDA report date
- Oct 23, 2024
- Quantity
- 11,214 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ACCORD HEALTHCARE, INC.
Original FDA data
Every field from FDA enforcement report D-0010-2025, exactly as published.
Show all FDA fields
- City
- Raleigh
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 95455
- Address
- 8041 Arco Corporate Dr Ste 200
- Code information
- Lot #: P2202009, Exp. Date: 03/2025
- Postal code
- 27617-2010
- Report date
- Oct 23, 2024
- Product type
- Drugs
- Recall number
- D-0010-2025
- Classification
- Class II
- Recalling firm
- ACCORD HEALTHCARE, INC.
- Product quantity
- 11,214 vials
- Termination date
- Feb 23, 2026
- Reason for recall
- Failed Impurities/Degradation Specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the United States and PR
- Recall initiation date
- Oct 1, 2024
- Initial firm notification
- Letter
- Center classification date
- Oct 11, 2024