CLASS II Drug recall · Reported 24 Jun 2020 · FDA Enforcement Report
Irinotecan HCL Injection, USP, 100mg/ vials recalled
Hikma Pharmaceuticals USA is recalling Irinotecan HCL Injection, USP, 100mg/ vials, distributed nationwide in the US. The recall was initiated on 11 Jun 2020 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-1309-2020
- FDA event ID
- 85831
- Recalling firm
- Hikma Pharmaceuticals USA, Cherry Hill, NJ
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jun 2020
- FDA classified
- 12 Jun 2020
- Reported
- 24 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 11 Jun 2020 | Recall initiated by company | |
| 12 Jun 2020 | Classified by FDA | +1 day |
| 24 Jun 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Product as listed by the FDA
Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC 0143-9583-01
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Which lots are affected?
Lot #:AC0231A, exp. date 08/2021
Where was it sold?
Nationwide within the United States
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 85831This product is part of a recall event; the main page for the event is Irinotecan HCL Injection, USP, 100mg/ vials recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Irinotecan HCL Injection, USP, 100mg/ vials recalledIrinotecan Hydrochloride | Hikma Pharmaceuticals USA | Other | Nationwide |
More recalls from Hikma Pharmaceuticals USA
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ramipril Capsules USP, 10 mg recalled by Hikma Pharmaceuticals USARamipril | Hikma Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Alendronate Sodium Oral Solution, 70 mg recalledAlendronate Sodium | Hikma Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Lorazepam Injection, USP, 2 mg/mL, 25 x vials/carton recalledLorazepam | Hikma Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS I | Acetaminophen Injection, 1,000 mg recalled by Hikma Pharmaceuticals USAAcetaminophen | Hikma Pharmaceuticals USA | Packaging Defects | OH, PR |
| Drug | CLASS II | Infumorph (Preservative-free Morphine Sulfate Sterile recalledInfumorph 200 | Hikma Pharmaceuticals USA | Other | 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 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 |
| Drug | CLASS II | Irinotecan Hydrochloride Injection, USP, 100 mg/ (20 mg/mL) recalled | Ingenus Pharmaceuticals | Potency & Assay | Nationwide |