Radioactive Diagnostic Agent
Where is Technetium Tc-99m Medronate made?
2 companies sell it under their own name. Their labels name 1 factory in the United States.
United States 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Sun Pharmaceutical Industries, Inc. Kit for the Preparation of Technetium Tc 99M Medronate20 mg per 10 mL · NDC 45567-0040 | Sun Pharmaceutical Industries, Inc.Makes it, tests it, packages it and labels it | Billerica, MA, United States | Problems found, fixed voluntarilyApr 2025 |
| Cardinal Health 414, LLC Kit for the Preparation of Technetium Tc 99m Medronate20 mg · NDC 65857-505 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Jun 6, 2018 · Class II · Pharmalucence, Inc.
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.