Reported Apr 1, 2020 · Terminated
DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION), 20 mg vial, Rx only, Manufactured…
Jubilant Draximage Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Jubilant Draximage Inc · 16751 Rte Transcanadienne · Kirkland, N/A · N/A
Is this the product you have?
- DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION), 20 mg vial, Rx only
- Manufactured forJubilant Draximage, Inc., Kirkland, Quebec, Canada, NDC 65174-288-05, 67175-288-30
- Lot codes and dates
Lot # 8K143Exp 10/31/2020
- Amount recalled
- 473 kits of 30 vials
Why it was recalled
Failed Stability Specifications
This product could cause temporary or reversible health problems — stop using it.
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