The Recall Desk
SevereFDA (Drugs)·D-66447-002·Announced 2013-11-13

FDA Recalls Irinotecan Hydrochloride Injection Due to Incorrect Formulation Calculation

West-Ward Pharmaceutical Corp. is recalling Irinotecan Hydrochloride Injection because an incorrect calculation resulted in an assay higher than the labeled claim.

What this means for you

Illness, injury, or structural failure has been reported. 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 and involves a superpotent drug with an incorrect formulation calculation resulting in an assay higher than the labeled claim, which meets the criteria for a Severe rating.

Plain-English summary

West-Ward Pharmaceutical Corp. is recalling 9,813 vials of Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), single-dose vials. The affected product is distributed nationwide and includes lots AC0026 and AC0027 with an expiration date of 10/14. The product is manufactured by Thymoorgan Pharmazie GmbH in Germany and distributed by West-Ward Pharmaceutical Corp. in Eatontown, NJ.

The recall was initiated because a recent 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 results in an assay that is higher than the labeled claim. Irinotecan is classified as a superpotent drug.

Healthcare providers and patients should stop using the affected vials and contact West-Ward Pharmaceutical Corp. for further instructions or to arrange for a return or replacement. The recall is classified as Class II by the FDA.

The recalled product

Product
IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
Brand
IRINOTECAN HYDROCHLORIDE
Manufacturer
West-Ward Pharmaceutical Corp.
Category
Drug — Injection
Hazard
Affected units
9,813

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 (3)

  • Lot #: AC0026
  • AC0027
  • Exp 10/14

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 →

Related recalls

Same brand · IRINOTECAN HYDROCHLORIDE

Same manufacturer · West-Ward Pharmaceutical Corp.

See all →

Same hazard · incorrect formulation

See all →