FDA recall D-1309-2020

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 0143-9583-01

Reason for recall

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

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2020-06-11

Report date

2020-06-24

Termination date

2021-06-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cherry Hill, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1309-2020