May 2013 FDA Recall Drug by Fusion Pharmaceuticals, Llc
D-1055-2014 - Microbial Contamination of Non-Sterile Products

This Class II drug recall was voluntarily initiated by Fusion Pharmaceuticals, Llc on May 8, 2013 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed in CA and the recall is currently terminated.

Recall Number: D-1055-2014

Reason for Recall
Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to Total Yeasts and Molds Count above USP limits.
Initiated
05-08-2013
Reported
02-12-2014
Quantity
1,200 kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66139
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fusion Pharmaceuticals, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-31-2014
Product Description About Product Description
Full technical description of the product.
Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML

Batch or Lot Expiration Information

Lot# Lots: PL520, PL521, PL522 and PL523