Recalls / Class II
Class IID-1308-2020
Product
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 0143-9701-01
- Brand name
- Irinotecan Hydrochloride
- Generic name
- Irinotecan Hydrochloride
- Active ingredient
- Irinotecan Hydrochloride
- Route
- Intravenous
- NDCs
- 0143-9701, 0143-9702
- FDA application
- ANDA091032
- Affected lot / code info
- Lot #: AC0231, AC0235, exp. date 08/2021; AC0237, exp. date 09/2021
Why it was recalled
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Recalling firm
- Firm
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Esterbrook Ln, Cherry Hill, New Jersey 08003-4002
Distribution
- Quantity
- 82,426 vials
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2020-06-11
- FDA classified
- 2020-06-12
- Posted by FDA
- 2020-06-24
- Terminated
- 2021-06-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1308-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.