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

FDA recall notice · announced April 1, 2020 · Jubilant Draximage

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Notes

Distribution: Product was distributed throughout the United States.
Lot/code information: Lot # 8K143, Exp 10/31/2020.
Quantity: 473 kits of 30 vials
Status: Terminated
Products in this recall event:
- 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, 67175-28 (D-1062-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.