Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1309-2020·Announced 2020-06-24

Hikma Recalls Irinotecan Hydrochloride Vials Due to Container Defect

Hikma Pharmaceuticals is recalling 17,998 vials of Irinotecan Hydrochloride Injection due to a crimp defect in the flip-cap.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, which corresponds to a moderate severity score under the rubric for minor labeling or packaging errors without reported serious injury.

Plain-English summary

Hikma Pharmaceuticals USA Inc. is recalling 17,998 vials of Irinotecan Hydrochloride Injection, USP, 100mg/5mL. The affected product is identified by Lot #AC0231A with an expiration date of 08/2021. The vials were distributed nationwide within the United States.

The recall was initiated due to customer complaints regarding a crimp defect observed while removing the flip-cap during use. This defect is classified as a defective container issue.

Healthcare providers and patients should stop using the affected vials and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product: IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
Brand: IRINOTECAN HYDROCHLORIDE
Manufacturer: Hikma Pharmaceuticals USA Inc.
Category: Drug — Injection
Hazard: container-defect
Affected units: 17,998

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 (2)

Lot #:AC0231A
exp. date 08/2021

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 →

Same brand · IRINOTECAN HYDROCHLORIDE

Moderate
Hikma Recalls Irinotecan Hydrochloride Injection Due to Container Defect
FDA (Drugs) · 2020-06-24
Severe
Ingenus Recalls Irinotecan Hydrochloride Injection Due to Potency Issues
FDA (Drugs) · 2018-07-11
Severe
Ingenus Recalls Irinotecan Hydrochloride Injection Due to Potency Issues
FDA (Drugs) · 2018-07-11
Severe
Irinotecan Hydrochloride Injection Recalled for Incorrect Formulation Calculation
FDA (Drugs) · 2013-11-13
Severe
FDA Recalls Irinotecan Hydrochloride Injection Due to Incorrect Formulation Calculation
FDA (Drugs) · 2013-11-13

Same manufacturer · Hikma Pharmaceuticals USA Inc.

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Same hazard · container defect