FDAFDA · Food and drugs·Recall number D-1308-2020
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
Published June 24, 2020 · Recall initiated: June 11, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- IRINOTECAN HYDROCHLORIDE
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Distributor
- Nationwide within the United States
- UPC
- 0301439701019
- Lot
- Lot #: AC0231, AC0235, exp. date 08/2021; AC0237, exp. date 09/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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