FDA Drug recall D-0891-2018
Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceutic…
- FDA Drug
- Class II
- terminated
- Published 2018-07-11
On 2018-07-11 the FDA classified a Class II recall of Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceutic… by Ingenus Pharmaceuticals, citing superpotent Drug: High out of specification assay value results for potency.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0891-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-08 |
| Published | 2018-07-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ingenus Pharmaceuticals |
| Distribution | US |
Product
Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-401-02.
Reason
Superpotent Drug: High out of specification assay value results for potency.
Identifiers
| ndc | 50742-401-02 |
|---|---|
| ndc | 50742-402-05 |
| code_info | Lot #: 17034-2, 17035-2, 17036-2; Exp. 08/19 |
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-0891-2018%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.