NDC 50090-6492
Mycophenolic Acid 360 mg tablet, delayed release
On the label: A-S Medication Solutions. It's repackaged: A-S Medication Solutions rebottles it from Ascend Laboratories, LLC's NDC 67877-427.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Alkem Laboratories Limited | Baddi Solan, India | Makes it, tests it and packages it | Problems found, fixed voluntarilyMar 27, 2024 · 9 inspections |
Repackaging site
- A-S Medication Solutions LLC, Libertyville, IL, United States · repackages it and relabels it
Recalls
- Sep 3, 2024 · Class II · Ascend Laboratories, LLC
Failed Dissolution Specifications
Lots: Lots 22123437, 22123438, 22123535, Exp Date 9/30/24; 22123536, 22123537, 22123538, 22123646, 22123647, Exp Date 10/31/24; 23120529, 23120530, Exp Date 1/31/25; 23120703, 23120705, Exp Date 2/28/25; 23121429, 23121726, 23122049, 23122097, Exp Date, 4/30/25; 23121984, 23121985, 23121986, Exp Date 5…
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
- tablet, delayed release, oral
- Strength
- 360 mg
- Approval
- ANDA ANDA208315
- On the market since
- Sep 24, 2021
- Package NDCs
50090-6492-0- Official label
- DailyMed (National Library of Medicine), updated May 23, 2023
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