NDC 50090-4318
Phenazopyridine Hydrochloride 200 mg tablet
On the label: A-S Medication Solutions. It's repackaged: A-S Medication Solutions rebottles it from Winder Laboratories, LLC's NDC 75826-115.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| PureTek Corporation | San Fernando, CA, United States | Makes it | Problems found, fixed voluntarilyMar 7, 2025 · 10 inspections |
| Winder Laboratories, LLC | Winder, GA, United States | Makes it | Serious problems, FDA actionAug 5, 2025 · 9 inspections, 2 with FDA action |
Repackaging site
- A-S Medication Solutions LLC, Libertyville, IL, United States · repackages it and relabels it
Recalls
- May 28, 2024 · Class II · Winder Laboratories, LLC
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Lots: Lot#: 1142404 Exp. Date 02/27/2027
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Phenazopyridine: every company that makes it
- Form
- tablet
- Strength
- 200 mg
- Approval
- unapproved drug other
- On the market since
- Nov 23, 2015
- Package NDCs
50090-4318-050090-4318-1- Official label
- DailyMed (National Library of Medicine), updated Jun 10, 2019
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