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

Class I - Dangerous
💊 Drugs Recalled: October 1, 2024 ACCORD HEALTHCARE Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #: P2202009, Exp. Date: 03/2025
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
ACCORD HEALTHCARE, INC.
Reason for Recall:
Failed Impurities/Degradation Specifications.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full 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 Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0010-2025

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