Class II — Potential Health Hazard

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

DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq Recalled by Fusion Pharmaceuticals, LLC Due to Microbial Contamination of a Non-Sterile Product: Kit component...

Date: March 6, 2015
Company: Fusion Pharmaceuticals, LLC
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 Fusion Pharmaceuticals, LLC directly.

Affected Products

DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq, 150 mL Kits, Rx Only. Fusion Pharmaceuticals LLC., 768 Calle Plano, Camarillo, CA 93012. NDC: 43093-104-01.

Quantity: 9,439 Kits

Why Was This Recalled?

Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.

Where Was This Sold?

California

About Fusion Pharmaceuticals, LLC

Fusion Pharmaceuticals, LLC has 2 total recalls tracked by RecallDetector.

Related Recalls

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