FDA Drug recall D-66447-002
Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Phar…
- FDA Drug
- Class II
- terminated
- Published 2013-11-13
On 2013-11-13 the FDA classified a Class II recall of Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Phar… by West Ward Pharmaceutical, citing superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an as….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-66447-002 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-23 |
| Published | 2013-11-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | West Ward Pharmaceutical |
| Distribution | US |
Product
Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Schiffgraben 23, 38690 Vienenburg, Germany; Distributed by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA, NDC 0143-9701-01.
Reason
Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.
Identifiers
| ndc | 0143-9702-01 |
|---|---|
| ndc | 0143-9701-01 |
| code_info | Lot #: AC0026, AC0027, Exp 10/14 |
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-66447-002%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.