Reported Jun 19, 2024 · Terminated

Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#:…

RemedyRepack Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: RemedyRepack Inc. · 625 Kolter Dr Ste 4 · Indiana, PA · 15701-3571

Is this the product you have?

  • Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only
  • Repackaged byRemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00
  • Source NDC75826-0114-10
  • MFGWinder Laboratories, LLC, Winder, GA
Lot codes and dates
    • Lot # B2906961-042524
    • exp. date 02/26/2027
Amount recalled
8 bottles

Why it was recalled

Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jul 1, 2024 · Data as of Sep 19, 5:06 PM UTC

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