NDC 43353-657
PredniSONE 5 mg tablet
On the label: Aphena Pharma Solutions - Tennessee, Inc.. It's repackaged: Aphena Pharma Solutions - Tennessee, Inc. rebottles it from Hikma Pharmaceuticals USA Inc.'s NDC 0054-4728.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| West-Ward Columbus Inc. | Columbus, OH, United States | Makes it | No problems foundApr 30, 2026 · 27 inspections |
Repackaging site
- Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, United States · repackages it
Recalls
- Oct 3, 2016 · Class II · West-Ward Pharmaceutical
Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
Lots: Lot # 660621A, Exp 01/31/18 - Jun 14, 2013 · Class III · Boehringer Ingelheim Roxane Inc
Labeling: Missing Label; missing label on blister card
Lots: The affected product consists of lot #261739A, expiration date OCT 2014.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Prednisone: every company that makes it
- Form
- tablet
- Strength
- 5 mg
- Approval
- ANDA ANDA080352
- On the market since
- Apr 21, 1972
- Package NDCs
43353-657-60- Official label
- DailyMed (National Library of Medicine), updated Dec 19, 2019
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