The Recall Desk
ModerateFDA (Drugs)·D-1308-2020·Announced 2020-06-24

Hikma Recalls Irinotecan Hydrochloride Injection Due to Container Defect

Hikma Pharmaceuticals is recalling 82,426 vials of Irinotecan Hydrochloride Injection due to a crimp defect in the flip-cap.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a container defect (crimp) without reported injuries or deaths, fitting the criteria for a moderate severity recall.

Plain-English summary

Hikma Pharmaceuticals USA Inc. is recalling 82,426 vials of Irinotecan Hydrochloride Injection, USP, 100mg/5mL. The recall is being conducted because of customer complaints regarding a crimp defect observed while removing the flip-cap during use.

The affected product is distributed nationwide within the United States. Specific lots involved in the recall are AC0231 and AC0235 with an expiration date of 08/2021, and lot AC0237 with an expiration date of 09/2021. The product is manufactured by Thymoorgan Pharmazie GmbH and distributed by West-Word Pharmaceutical Corp.

Healthcare providers and patients should stop using the affected vials and contact their pharmacist or the recalling firm for instructions on how to return the product.

The recalled product

Product
IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
Brand
IRINOTECAN HYDROCHLORIDE
Manufacturer
Hikma Pharmaceuticals USA Inc.
Category
Drug — Antineoplastic
Hazard
Affected units
82,426

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Lot #: AC0231
  • AC0235
  • exp. date 08/2021
  • AC0237
  • exp. date 09/2021

UPCs (1)

  • 0301439701019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Hikma Pharmaceuticals USA Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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Same brand · IRINOTECAN HYDROCHLORIDE

Same manufacturer · Hikma Pharmaceuticals USA Inc.

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Same hazard · container defect

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