Irinotecan HCL Injection recall
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
Why was Irinotecan HCL Injection recalled?
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: AC0231, AC0235, exp. date 08/2021; AC0237, exp. date 09/2021
- 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
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
- Quantity
- 82,426 vials
- Distribution
- Nationwide within the United States
- Recall date
- June 24, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)