Drug 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 0143-9583-01
D-1309-2020
Product summary
- Event
- Event 85831
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,998 vials
- Official record key
drug-enforcement:D-1309-2020
Official wording
Reason: Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Code information: Lot #:AC0231A, exp. date 08/2021
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.