FDA Drug recall D-915-2013
IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Scha…
- FDA Drug
- Class II
- terminated
- Published 2013-08-28
On 2013-08-28 the FDA classified a Class II recall of IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Scha… by Fresenius Kabi Usa Fk Usa, citing crystallization: Active pharmaceutical ingredient is precipitating in product solution.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-915-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-22 |
| Published | 2013-08-28 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fresenius Kabi Usa Fk Usa |
| Distribution | US |
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
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
Identifiers
| upc | 363323193027 |
|---|---|
| code_info | Lot #: 872CZ00101, Exp 12/13 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-915-2013%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.