Reported Jun 24, 2020 · Terminated
Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben…
Hikma Pharmaceuticals USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hikma Pharmaceuticals USA Inc. · 2 Esterbrook Ln · Cherry Hill, NJ · 08003-4002
Is this the product you have?
- Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only
- Manufactured by
Thymoorgan Pharmazie GmbHShiffgraben 2338690 Golsar
- Germany Distributed by
West-Word Pharmaceutical Corp. EatontownNJ 07724 USANDC 0143-9583-01
- Lot codes and dates
Lot #:AC0231Aexp. date 08/2021
- Amount recalled
- 17,998 vials
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Hikma Pharmaceuticals USA Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.