Irinotecan HCL Injection — Class II drug recall D-1309-2020
Terminated recall by Hikma Pharmaceuticals USA Inc., reported 2020-06-24, distributed nationwide. Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
| Recall number | D-1309-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hikma Pharmaceuticals USA Inc., Cherry Hill, NJ, United States |
| Recall initiated | 2020-06-11 |
| Classified | 2020-06-12 |
| Reported by FDA | 2020-06-24 |
| Terminated | 2021-06-10 |
| Distributed | Nationwide (US) |
| Quantity | 17,998 vials |
| Reason classes | packaging |
| NDC | 00143-9583, 00143-9583-01 |
| Lot numbers | AC0231A |
| Expiration dates | 2021-08 |
Product
Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC 0143-9583-01
Reason for recall
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1309-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.