CLASS II Drug recall · Reported 11 Jul 2018 · FDA Enforcement Report
Irinotecan Hydrochloride Injection, USP, 40 mg/ (20 mg/mL) recalled
Ingenus Pharmaceuticals is recalling Irinotecan Hydrochloride Injection, USP, 40 mg/ (20 mg/mL), mL Single Dose Vial, distributed nationwide in the US. The recall was initiated on 8 Jun 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0891-2018
- FDA event ID
- 80254
- Recalling firm
- Ingenus Pharmaceuticals, Orlando, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Jun 2018
- FDA classified
- 29 Jun 2018
- Reported
- 11 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 8 Jun 2018 | Recall initiated by company | |
| 29 Jun 2018 | Classified by FDA | +21 days |
| 11 Jul 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent Drug: High out of specification assay value results for potency.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Superpotent Drug: High out of specification assay value results for potency.
Which lots are affected?
Lot #: 17034-2, 17035-2, 17036-2; Exp. 08/19
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 6 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 80254This product is part of a recall event; the main page for the event is Irinotecan Hydrochloride Injection, USP, 100 mg/ (20 mg/mL) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Irinotecan Hydrochloride Injection, USP, 100 mg/ (20 mg/mL) recalled | Ingenus Pharmaceuticals | Potency & Assay | Nationwide |
More recalls from Ingenus Pharmaceuticals
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Flunisolide Nasal Solution recalled by Ingenus PharmaceuticalsFlunisolide | Ingenus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Clobetasol Propionate Foam recalled by Ingenus Pharmaceuticals | Ingenus Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Leucovorin Calcium Injection, USP 500 mg*/ (10 mg/mL) Single-Dose recalled | Ingenus Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS III | Diclofenac Sodium Topical Solution, 1.5% w/w recalled | Ingenus Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Irinotecan Hydrochloride Injection, USP, 100 mg/ (20 mg/mL) recalled | Ingenus Pharmaceuticals | Potency & Assay | Nationwide |
Other Irinotecan recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Irinotecan Hydrochloride Injection, USP, 40 mg recalled | Areva Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Irinotecan HCL Injection, USP, 100mg/ vials recalledIrinotecan Hydrochloride | Hikma Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Irinotecan HCL Injection, USP, 100mg/ vials recalledIrinotecan Hydrochloride | Hikma Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Irinotecan 250 MG / D5w Ivpb recalled by Infusion Options | Infusion Options | Sterility | NY |
| Drug | CLASS II | Irinotecan Hydrochloride Injection, USP, 100 mg/ (20 mg/mL) recalled | Ingenus Pharmaceuticals | Potency & Assay | Nationwide |