NDC 45567-0655
Kit for the Preparation of Technetium Tc99m Mertiatide 1 mg injection, powder, lyophilized, for solution
On the label: Sun Pharmaceutical Industries, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharmaceutical Industries, Inc. | Billerica, MA, United States | Makes it | Problems found, fixed voluntarilyApr 18, 2025 · 15 inspections |
Recalls
- Sep 3, 2025 · Class II · Sun Pharmaceutical Industries Inc
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Lots: Lot# AD70995; Exp 10/31/2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Betiatide: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 1 mg
- Approval
- ANDA ANDA208994
- On the market since
- Sep 2, 2019
- Package NDCs
45567-0655-1- Official label
- DailyMed (National Library of Medicine), updated Sep 10, 2024
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