FDAClass IIApril 1, 2020

Draximage Dtpa recall

DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION), 20 mg vial, Rx only, Manufactured for: Jubilant Draximage, Inc.…

Why was Draximage Dtpa recalled?

Failed Stability Specifications

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION), 20 mg vial, Rx only, Manufactured for: Jubilant Draximage, Inc.…
Recalling firm
Jubilant Draximage Inc
Quantity
473 kits of 30 vials
Distribution
Product was distributed throughout the United States.
Recall date
April 1, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls