Recall archive / FDA drug enforcement
Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70... — FDA record D-0549-2024
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 31, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Quantity
- 8 bottles
- Agency-reported status
- Terminated
- Source record identifier
- D-0549-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot # B2906961-042524, exp. date 02/26/2027 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Product was distributed to one medical facility.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jun 19, 2024
- Recall initiation date
- May 31, 2024
- Center classification date
- Jun 10, 2024
- Termination date
- Jul 1, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.