Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Irinotecan Hydrochloride Injection Recalled by West-Ward Pharmaceutical Corp. Due to Superpotent Drug: a recent review of the USP...

Date: September 23, 2013
Company: West-Ward Pharmaceutical Corp.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact West-Ward Pharmaceutical Corp. directly.

Affected Products

Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Schiffgraben 23, 38690 Vienenburg, Germany; Distributed by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA, NDC 0143-9702-01.

Quantity: 9020 vials

Why Was This Recalled?

Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About West-Ward Pharmaceutical Corp.

West-Ward Pharmaceutical Corp. has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report