FDA Drug recall D-1308-2020
Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Ge…
- FDA Drug
- Class II
- terminated
- Published 2020-06-24
On 2020-06-24 the FDA classified a Class II recall of Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Ge… by Hikma Pharmaceuticals Usa, citing defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1308-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-06-11 |
| Published | 2020-06-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Hikma Pharmaceuticals Usa |
| Distribution | US |
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 0143-9701-01
Reason
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Identifiers
| ndc | 0143-9702-01 |
|---|---|
| ndc | 0143-9701-01 |
| code_info | Lot #: AC0231, AC0235, exp. date 08/2021; AC0237, exp. date 09/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1308-2020%22
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