CLASS II Drug recall · Reported 13 Nov 2013 · FDA Enforcement Report
Irinotecan Hydrochloride Injection, 100 mg/ (20 mg/mL) recalled
West-Ward Pharmaceutical is recalling Irinotecan Hydrochloride Injection, 100 mg/ (20 mg/mL), mL Single Dose Vial per, distributed nationwide in the US. The recall was initiated on 23 Sep 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-66447-002
- FDA event ID
- 66447
- Recalling firm
- West-Ward Pharmaceutical, Eatontown, NJ
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Sep 2013
- FDA classified
- 4 Nov 2013
- Reported
- 13 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 23 Sep 2013 | Recall initiated by company | |
| 4 Nov 2013 | Classified by FDA | +42 days |
| 13 Nov 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #: AC0026, AC0027, Exp 10/14
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.
Other products in this recall event
1 other product · FDA event 66447| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Irinotecan Hydrochloride Injection, 40 mg/ (20 mg/mL) recalledIrinotecan Hydrochloride | West-Ward Pharmaceutical | Potency & Assay | Nationwide |
More recalls from West-Ward Pharmaceutical
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | PredniSONE Tablets USP, 1 mg recalled by West-Ward PharmaceuticalPrednisone | West-Ward Pharmaceutical | Other | Nationwide |
| Drug | CLASS III | Fentanyl Citrate Inj., USP, CII, 250 mcg/ (50 mcg/mL) (0.05 mg/mL) recalledFentanyl Citrate | West-Ward Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS III | Fentanyl Citrate Inj., USP, CII, 250 mcg/ (50 mcg/mL) recalledFentanyl Citrate | West-Ward Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS II | Versapharm Incorporated Ethambutol Hydrochloride Tablets recalled | West-Ward Pharmaceutical | Potency & Assay | GA |
| Drug | CLASS II | Isoniazid Tablets, USP, 300 mg recalled by West-Ward Pharmaceutical | West-Ward Pharmaceutical | Potency & Assay | 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) recalled | Ingenus Pharmaceuticals | Potency & Assay | Nationwide |