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
Reported: June 24, 2020 Initiated: June 11, 2020 #D-1308-2020
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 0143-9701-01
Reason for Recall
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Details
- Recalling Firm
- Hikma Pharmaceuticals USA Inc.
- Units Affected
- 82,426 vials
- Distribution
- Nationwide within the United States
- Location
- Cherry Hill, NJ
Frequently Asked Questions
What product 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. Recalled by Hikma Pharmaceuticals USA Inc.. Units affected: 82,426 vials.
Why was this product recalled? ▼
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 24, 2020. Severity: Moderate. Recall number: D-1308-2020.
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