March 2015 FDA Recall Drug by Fusion Pharmaceuticals, Llc
D-0410-2015 - Microbial Contamination of a Non-Sterile Product

This Class II drug recall was voluntarily initiated by Fusion Pharmaceuticals, Llc on March 6, 2015 for the product Drug. The FDA reported the reason for recall as microbial contamination of a non-sterile product. The product was distributed in California and the recall is currently terminated.

Recall Number: D-0410-2015

Reason for Recall
Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
Initiated
03-06-2015
Reported
03-18-2015
Quantity
9,439 Kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70682
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.
California
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2015
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# Lot Numbers: PL713, PL714, PL715, PL716, PL717, PL718, PL719, PL720, PL721, PL722, PL735, PL736, PL737, PL738, PL739, PL740, PL741, PL742, PL743, PL744; Expiry: 7/20/2015.