NDC 45567-0455
Kit for the Preparation of Technetium Tc 99m Mebrofenin 45 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 | Problems found, fixed voluntarilyApr 18, 2025 · 15 inspections |
Recalls
- Apr 10, 2018 · Class II · Pharmalucence, Inc.
Failed Stability Specifications
Lots: Part Number MEM05 and MEB30 both with expiry date 12/2018
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Mebrofenin: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 45 mg per 10 mL
- Approval
- ANDA ANDA078242
- On the market since
- Jan 29, 2008
- Package NDCs
45567-0455-145567-0455-2- Official label
- DailyMed (National Library of Medicine), updated Aug 28, 2024
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