FDA Drug recall D-0890-2018
Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuti…
- 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, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuti… 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-0890-2018 |
| 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, 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
Superpotent Drug: High out of specification assay value results for potency.
Identifiers
| ndc | 50742-401-02 |
|---|---|
| ndc | 50742-402-05 |
| code_info | Lot #: 17034-1, 17035-1, 17036-1; 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.
Other recalls by Ingenus Pharmaceuticals
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FDA Drug · Class II · 2022-10-26 · Ingenus Pharmaceuticals - Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only, Manufactured f…
FDA Drug · Class II · 2022-01-26 · Ingenus Pharmaceuticals - Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. Or…
FDA Drug · Class II · 2019-10-23 · Ingenus Pharmaceuticals - Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx Only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando,…
FDA Drug · Class III · 2019-04-03 · Ingenus Pharmaceuticals - 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 · 2018-07-11 · Ingenus Pharmaceuticals
All Ingenus Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0890-2018%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.