Status
Terminated
Drug Enforcement D-0549-2024
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Classification
Class II
Report Date
June 19, 2024
Termination Date
July 1, 2024
Product Information
- 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
- Product quantity
- 8 bottles
- Reason for recall
- Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed to one medical facility.
Location & Firm
- Recalling firm
- RemedyRepack Inc.
- Address
-
625 Kolter Dr Ste 4, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0549-2024
- Event ID
- 94738
- Recall initiation date
- May 31, 2024
- Center classification date
- June 10, 2024
- Code info
- Lot # B2906961-042524, exp. date 02/26/2027
- More code info
- —