# FDA recall D-0549-2024

> **RemedyRepack Inc.** · Class II · drug recall initiated 2024-05-31.

## Product

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.

## Distribution

Product was distributed to one medical facility.

## Key facts

- **Recall number:** D-0549-2024
- **Recalling firm:** RemedyRepack Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-05-31
- **Report date:** 2024-06-19
- **Termination date:** 2024-07-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indiana, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0549-2024

## Citation

> AI Analytics. FDA recall D-0549-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0549-2024. Source: US FDA. Licensed CC0.

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