Irinotecan Hydrochloride Injection — Class II drug recall D-0890-2018
Terminated recall by Ingenus Pharmaceuticals Llc, reported 2018-07-11, distributed nationwide. Superpotent Drug: High out of specification assay value results for potency.
| Recall number | D-0890-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ingenus Pharmaceuticals Llc, Orlando, FL, United States |
| Recall initiated | 2018-06-08 |
| Classified | 2018-06-29 |
| Reported by FDA | 2018-07-11 |
| Terminated | 2019-05-01 |
| Distributed | Nationwide (US) |
| Quantity | 34,964 vials |
| Reason classes | potency, specification failure |
| NDC | 50742-0401, 50742-0401-02, 50742-0402, 50742-0402-05 |
| Lot numbers | 08/19, 17034-1, 17035-1, 17036-1 |
Product
Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-402-05.
Reason for recall
Superpotent Drug: High out of specification assay value results for potency.
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-0890-2018. 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.