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
Reported: October 23, 2024 Initiated: October 1, 2024 #D-0010-2025
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
Reason for Recall
Failed Impurities/Degradation Specifications.
Details
- Recalling Firm
- ACCORD HEALTHCARE, INC.
- Units Affected
- 11,214 vials
- Distribution
- Nationwide within the United States and PR
- Location
- Raleigh, NC
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by ACCORD HEALTHCARE, INC.. Units affected: 11,214 vials.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 23, 2024. Severity: Moderate. Recall number: D-0010-2025.
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