FDA-Drug2020-06-24Class II
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
Hikma Pharmaceuticals USA Inc.
Hazard
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Sold states
Nationwide within the United States
Affected count
17,998 vials
Manufactured in
2 Esterbrook Ln, Cherry Hill, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1309-2020Don't want to check this manually?
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