CLASS II Drug recall · Reported 28 Aug 2013 · FDA Enforcement Report
Irinotecan Hydrochloride Injection, 40 mg recalled
Fresenius Kabi USA LLC (FK USA) is recalling Irinotecan Hydrochloride Injection, 40 mg/ (20 mg/mL) Single Dose Vial, distributed nationwide in the US. The recall was initiated on 22 Jan 2013 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-915-2013
- FDA event ID
- 64102
- Recalling firm
- Fresenius Kabi USA LLC (FK USA), Schaumburg, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Jan 2013
- FDA classified
- 21 Aug 2013
- Reported
- 28 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 22 Jan 2013 | Recall initiated by company | |
| 21 Aug 2013 | Classified by FDA | +211 days |
| 28 Aug 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
Product as listed by the FDA
IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
Which lots are affected?
Lot #: 872CZ00101, Exp 12/13
Where was it sold?
Nationwide
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fresenius Kabi USA LLC (FK USA)
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Calcium Gluconate Injection, USP, 10% (100 mg/mL), Single Dose Vial recalled | Fresenius Kabi USA LLC (FK USA) | Labeling Errors | 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, 40 mg/ (20 mg/mL) recalledIrinotecan Hydrochloride | Ingenus Pharmaceuticals | Potency & Assay | Nationwide |