Hikma Pharmaceuticals USA Inc. recalls Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 2
Recalled June 24, 2020 · FDA recall D-1308-2020 · Hikma Pharmaceuticals USA
Hazard
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use. · FDA Class II
Units
82,426 vials
Sold at
Nationwide within the United States
Description
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
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
Manufacturer(s)
Hikma Pharmaceuticals USA Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →