IRINOTECAN HYDROCHLORIDE INJECTION — Class II drug recall D-915-2013
Terminated recall by Fresenius Kabi USA LLC (FK USA), reported 2013-08-28, distributed nationwide. Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
| Recall number | D-915-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA LLC (FK USA), Schaumburg, IL, United States |
| Recall initiated | 2013-01-22 |
| Classified | 2013-08-21 |
| Reported by FDA | 2013-08-28 |
| Terminated | 2015-05-12 |
| Distributed | Nationwide (US) |
| Quantity | 23,672 vials |
| UPC / GTIN / UDI-DI | 00363323193027 |
| NDC | 63323-0193-02 |
| Lot numbers | 12/13, 872CZ00101 |
Product
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.
Reason for recall
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
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-915-2013. 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.