Recall: D-1308-2020

Class II - Potentially Harmful

Class IIClassification

2020-06-11Initiated

TerminatedStatus

Hikma Pharmaceuticals USA Inc.Firm

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

Reason

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

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.