D-1309-2020 Class II Terminated
FDA drug recall D-1309-2020 was initiated by Hikma Pharmaceuticals USA Inc. on Jun 11, 2020 and is designated Class II. Reason for recall: Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use. The recall status is terminated (terminated Jun 10, 2021). Affected quantity: 17,998 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 24, 2020
- Initiation Date
- Jun 11, 2020
- Termination Date
- Jun 10, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,998 vials
Product Description
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 Pattern
Nationwide within the United States
Code Information
Lot #:AC0231A, exp. date 08/2021