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 # B2906961-042524exp. 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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