CLASS II Drug recall · Reported 23 Oct 2024 · FDA Enforcement Report
Cisplatin Injection, 100mg/ (1mg/mL) recalled by Accord Healthcare
Accord Healthcare is recalling Cisplatin Injection, 100mg/ (1mg/mL), For Intravenous Use Multiple Dose Vial, distributed nationwide in the US. The recall was initiated on 1 Oct 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0010-2025
- FDA event ID
- 95455
- Recalling firm
- Accord Healthcare, Raleigh, NC
- Brand
- Cisplatin
- Manufacturer
- Accord Healthcare Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Oct 2024
- FDA classified
- 11 Oct 2024
- Reported
- 23 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 1 Oct 2024 | Recall initiated by company | |
| 11 Oct 2024 | Classified by FDA | +10 days |
| 23 Oct 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States and PR
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications.
Which lots are affected?
Lot #: P2202009, Exp. Date: 03/2025
Where was it sold?
Nationwide within the United States and PR
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Accord Healthcare
All 106| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
Other Cisplatin recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cisplatin 40 MG / NS Ivpb With Mannitol recalled by Infusion Options | Infusion Options | Sterility | NY |
| Drug | CLASS II | Cisplatin 40 MG / NS Ivpb With Mannitol recalled by Infusion Options | Infusion Options | Sterility | NY |
| Drug | CLASS II | Cisplatin 1mg/ML Injectable (2 Different Products) recalled | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Sterility | Nationwide |