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
Reported: April 1, 2020 Initiated: March 19, 2020 #D-1062-2020
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
Details
- Recalling Firm
- Jubilant Draximage Inc
- Units Affected
- 473 kits of 30 vials
- Distribution
- Product was distributed throughout the United States.
- Location
- Kirkland, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Jubilant Draximage Inc. Units affected: 473 kits of 30 vials.
Why was this product recalled? ▼
Failed Stability Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 1, 2020. Severity: Moderate. Recall number: D-1062-2020.
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