FDA Drug recall D-0010-2025
Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare Inc…
- FDA Drug
- Class II
- terminated
- Published 2024-10-23
On 2024-10-23 the FDA classified a Class II recall of Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare Inc… by Accord Healthcare, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0010-2025 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-10-01 |
| Published | 2024-10-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Accord Healthcare |
| Distribution | US |
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
Reason
Failed Impurities/Degradation Specifications.
Identifiers
| ndc | 16729-288-11 |
|---|---|
| ndc | 16729-288-38 |
| code_info | Lot #: P2202009, Exp. Date: 03/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Accord Healthcare
- Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 2…
FDA Drug · Class II · 2026-09-02 · Accord Healthcare - Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 2…
FDA Drug · Class II · 2026-09-02 · Accord Healthcare - Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC 16729-451-15) and b) 1000-count bottles, (NDC 167…
FDA Drug · Class II · 2026-09-02 · Accord Healthcare - Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 1…
FDA Drug · Class II · 2026-09-02 · Accord Healthcare - Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 2761…
FDA Drug · Class II · 2026-09-02 · Accord Healthcare
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0010-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.