NDC 45567-0040
Kit for the Preparation of Technetium Tc 99M Medronate 20 mg per 10 mL 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, tests it, packages it and labels it | Problems found, fixed voluntarilyApr 18, 2025 · 15 inspections |
Recalls
- Jun 6, 2018 · Class II · Pharmalucence, Inc.
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Lots: Lot 4223
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Technetium Tc-99m Medronate: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 20 mg per 10 mL
- Approval
- NDA NDA018124
- On the market since
- Aug 29, 1979
- Package NDCs
45567-0040-145567-0040-2- Official label
- DailyMed (National Library of Medicine), updated Mar 11, 2025
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