Class II · Moderate risk
Kit for the Preparation of Technetium Tc 99m Mertiatide
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Draximage Dtpa
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Stability Specifications
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What 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
Affected NDCs
65174-0288-05
67175-0288-30
Compare with the code on your package — it is the most precise check available.
Drug: Technetium
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Draximage Dtpa Kit for the preparation of Technetium Tc 99m Pentetate NDC 65174-0288 |
PENTETIC ACID 20 mg/1 | Injection, Powder, Lyophilized, for Solution Intravenous|respiratory (inhalation) |
Jubilant DraxImage Inc., dba Jubilant Radiopharma | Rx |
- Recalling firm
- Jubilant Draximage Inc
- NDC code
- 65174-288-05
- Origin
- N/A, Canada
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1062-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Technetium recalls
See all
Class II · Moderate risk
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Class II · Moderate risk
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection
Failed Stability Specifications
Class II · Moderate risk
Kit for the Preparation of Technetium Tc99m Medronate
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Class II · Moderate risk
Kit for the Preparation of Technetium TC-99M Mebrofenin
Failed Stability Specifications
Other recalls by Jubilant Draximage Inc
All 2020 recalls
Class II · Moderate risk
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection
Failed Stability Specifications
Class II · Moderate risk
Draximage MAA
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Class III · Low risk
Sodium Iodide I 131 Capsule
Labeling: Label Error on Declared Strength
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