Hikma Pharmaceuticals USA Inc. recalls Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben…
- Recall date
- June 11, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1308-2020
- FDA classification
- Class II
- Brand / firm
- Hikma Pharmaceuticals USA Inc.
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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