Irinotecan Hydrochloride Injection — Class II drug recall D-66447-001
Terminated recall by West-Ward Pharmaceutical Corp., reported 2013-11-13, distributed nationwide. Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the
| Recall number | D-66447-001 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | West-Ward Pharmaceutical Corp., Eatontown, NJ, United States |
| Recall initiated | 2013-09-23 |
| Classified | 2013-11-04 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2016-04-05 |
| Distributed | Nationwide (US) |
| Quantity | 9,020 vials |
| Reason classes | labeling, potency |
| NDC | 00143-9701, 00143-9701-01, 00143-9702, 00143-9702-01 |
| Lot numbers | 03/14, 08/14, AC0020, AC0023, AC0025 |
Product
Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 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 0143-9702-01.
Reason for recall
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.
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-66447-001. 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.