NDC 67457-386
Mycophenolate Mofetil 500 mg per 20 mL injection, powder, lyophilized, for solution
On the label: Mylan Institutional LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Mylan Laboratories Limited | Bengaluru, India | Makes it, tests it, packages it, labels it and sterilizes it | No problems foundFeb 24, 2023 · 8 inspections, 2 with FDA action |
Recalls
- Aug 26, 2026 · Class II · Mylan Pharmaceuticals Inc
Failed Dissolution Specifications
Lots: Lot: 3242616, Exp. April 2027; 8220216, Exp. Nov 2027 - Jul 2, 2026 · Class II · Mylan Pharmaceuticals Inc
Presence of precipitate
Lots: Lot #: 3241653, Exp 4/30/2027
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Mycophenolic Acid: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 500 mg per 20 mL
- Approval
- ANDA ANDA203859
- On the market since
- Jan 26, 2021
- Package NDCs
67457-386-0067457-386-81- Official label
- DailyMed (National Library of Medicine), updated Jul 15, 2025
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?