FDA-Drug2024-06-19Class II
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
RemedyRepack Inc.
Hazard
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Sold states
Product was distributed to one medical facility.
Affected count
8 bottles
Manufactured in
625 Kolter Dr Ste 4, N/A, Indiana, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0549-2024Don't want to check this manually?
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