Cisplatin Injection recall
FDA recall D-0010-2025 · initiated Oct 1, 2024
ACCORD HEALTHCARE, INC. recalled Cisplatin Injection in Oct 2024 — an FDA Class II recall (D-0010-2025) because Failed Impurities/Degradation Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 11,214 vials
Details
- 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
- Recalling company
- ACCORD HEALTHCARE, INC.
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States and PR
- Initiated
- Oct 1, 2024
- FDA report date
- Oct 23, 2024
This recall is linked to a product we cover: Cisplatin →
Frequently asked
- Was Cisplatin Injection recalled?
- ACCORD HEALTHCARE, INC. recalled Cisplatin Injection in Oct 2024 — an FDA Class II recall (D-0010-2025) because Failed Impurities/Degradation Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Cisplatin Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0010-2025 was: Failed Impurities/Degradation Specifications.
- Is a recalled Cisplatin Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Cisplatin Injection are affected?
- Distributed: Nationwide within the United States and PR. The recall covers these lots — Lot #: P2202009, Exp. Date: 03/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0010-2025.