The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-66447-001·Announced 2013-11-13

Irinotecan Hydrochloride Injection Recalled for Incorrect Formulation Calculation

West-Ward Pharmaceutical Corp. is recalling Irinotecan Hydrochloride Injection because a calculation error resulted in drug levels higher than labeled.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant potential health risks.

Plain-English summary

West-Ward Pharmaceutical Corp. is recalling specific lots of Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), single-dose vials. The recall involves 9,020 vials distributed nationwide. The affected lots are AC0020 (Exp 03/14), AC0023, and AC0025 (Exp 08/14).

The recall was initiated after a review of the United States Pharmacopeia (USP) revealed that an incorrect calculation was used to determine the amount of irinotecan used in the formulation. This error resulted in an assay that is higher than the labeled claim. The product is a superpotent drug intended for intravenous use.

Healthcare providers and pharmacies should stop using the affected lots and contact West-Ward Pharmaceutical Corp. for further instructions. Patients who have received the medication should consult their healthcare provider if they have questions or concerns.

The recalled product

Product
IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
Brand
IRINOTECAN HYDROCHLORIDE
Manufacturer
West-Ward Pharmaceutical Corp.
Category
Drug — Antineoplastic
Hazard
Affected units
9,020

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 #: AC0020
  • Exp 03/14
  • AC0023
  • AC0025
  • Exp 08/14

UPCs (1)

  • 0301439701019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by West-Ward Pharmaceutical Corp. 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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