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 0143-9701-01
- Lot codes and dates
Lot #: AC0231AC0235exp. date 08/2021AC0237exp. date 09/2021
- Amount recalled
- 82,426 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.
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