FDAHealthOctober 1, 2024
ACCORD HEALTHCARE, INC. — 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 b
⚠️ Failed Impurities/Degradation Specifications.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 1, 2024
Nationwide within the United States and PR
What's affected?
- 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
- CISPLATIN
- UPC
- 0316729288385
- Lot code
- P2202009
Additional details
Lot #: P2202009, Exp. Date: 03/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 11,214 vials.
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