Class II · Moderate risk
Phenazopyridine HCl Tablets USP
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Phenazopyridine HCl
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source NDC: 75826-0114-10 MFG: Winder Laboratories, LLC, Winder, GA
Affected NDCs
70518-0218-00
75826-0114-10
Compare with the code on your package — it is the most precise check available.
Drug: Phenazopyridine
Product details
From the FDA NDC directory, for the product codes this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Phenazopyridine Hydrochloride NDC 70518-0218 |
100 mg/1 | Tablet Oral |
Remedyrepack INC. | Rx |
| Phenazopyridine Hydrochloride NDC 75826-0114 |
100 mg/1 | Tablet Oral |
Winder Laboratories, LLC | Rx |
- Recalling firm
- RemedyRepack Inc.
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0549-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Phenazopyridine recalls
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Class II · Moderate risk
Phenazopyridine Hydrochloride Tablets
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Class II · Moderate risk
Phenazopyridine Hydrochloride Tablets
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Class II · Moderate risk
Phenazopyridine Hydrochloride Tablets
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
Phenazopyridine Hydrochloride Tablets
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
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