NDC 70518-0218
Phenazopyridine Hydrochloride 100 mg tablet
On the label: Remedyrepack Inc.. It's repackaged: Remedyrepack Inc. rebottles it from Winder Laboratories, LLC's NDC 75826-114.
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 |
Recalls
- May 31, 2024 · Class II · RemedyRepack Inc.
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Lots: Lot # B2906961-042524, exp. date 02/26/2027 - 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, oral
- Strength
- 100 mg
- Approval
- unapproved drug other
- On the market since
- Feb 14, 2017
- Package NDCs
70518-0218-070518-0218-170518-0218-270518-0218-3- Official label
- DailyMed (National Library of Medicine), updated Jun 24, 2026
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