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

FDA recall notice · announced June 24, 2020 · Hikma Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot #: AC0231, AC0235, exp. date 08/2021; AC0237, exp. date 09/2021
Quantity: 82,426 vials
Status: Terminated
Products in this recall event:
- 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. Eatontow (D-1309-2020)
- 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. Eatontow (D-1308-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.