FDA Drugs recall ·
Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use… recall
- Recall number
- D-0010-2025
- Date
- (initiated October 1, 2024)
- Company / brand
- Accord Healthcare, Inc.
8041 Arco Corporate Dr Ste 200, Raleigh, NC, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Terminated
- Units affected
- 11,214 vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Failed Impurities/Degradation Specifications.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: P2202009, Exp. Date: 03/2025
Distribution
Nationwide within the United States and PR
States: Puerto Rico
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0010-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.