D-1062-2020 Class II Terminated

Recalled by Jubilant Draximage Inc — Kirkland, N/A

Recall Details

Product Type
Drugs
Report Date
April 1, 2020
Initiation Date
March 19, 2020
Termination Date
May 19, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
473 kits of 30 vials

Product Description

DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION), 20 mg vial, Rx only, Manufactured for: Jubilant Draximage, Inc., Kirkland, Quebec, Canada, NDC 65174-288-05, 67175-288-30

Reason for Recall

Failed Stability Specifications

Distribution Pattern

Product was distributed throughout the United States.

Code Information

Lot # 8K143, Exp 10/31/2020.