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
Reported: June 19, 2024 Initiated: May 31, 2024 #D-0549-2024
Product Description
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
Reason for Recall
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Details
- Recalling Firm
- RemedyRepack Inc.
- Units Affected
- 8 bottles
- Distribution
- Product was distributed to one medical facility.
- Location
- Indiana, PA
Frequently Asked Questions
What product 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. Recalled by RemedyRepack Inc.. Units affected: 8 bottles.
Why was this product recalled? ▼
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 19, 2024. Severity: Moderate. Recall number: D-0549-2024.
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