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Recall Observatory FDA recall evidence

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 0143-9701-01

D-1308-2020

June 11, 2020

Class II

Product summary

Firm
Hikma Pharmaceuticals USA Inc.
Event
Event 85831
Status
Terminated
Classification
Class II
Quantity
82,426 vials
Official record key
drug-enforcement:D-1308-2020

Official wording

Reason: Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.

Code information: Lot #: AC0231, AC0235, exp. date 08/2021; AC0237, exp. date 09/2021

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.