Recalls / Class II
Class IID-0549-2024
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
- Affected lot / code info
- Lot # B2906961-042524, exp. date 02/26/2027
Why it was recalled
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, N/A, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 8 bottles
- Distribution pattern
- Product was distributed to one medical facility.
Timeline
- Recall initiated
- 2024-05-31
- FDA classified
- 2024-06-10
- Posted by FDA
- 2024-06-19
- Terminated
- 2024-07-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0549-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.