US Drug Recall Register
Class II · Moderate risk Terminated Initiated May 8, 2013 (13 years ago)

Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to Total Yeasts and Molds Count above USP limits.

What was recalled

Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML

Recalling firm
Fusion Pharmaceuticals, LLC
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1055-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.