Why it was recalled
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
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
Lot numbers, UPCs & expiration codes
Lot # B2906961-042524, exp. date 02/26/2027
Where it was sold
Product was distributed to one medical facility.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0549-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 31, 2024
- FDA report date
- Jun 19, 2024
- Quantity
- 8 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-0549-2024, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 94738
- Address
- 625 Kolter Dr Ste 4
- Code information
- Lot # B2906961-042524, exp. date 02/26/2027
- Postal code
- 15701-3571
- Report date
- Jun 19, 2024
- Product type
- Drugs
- Recall number
- D-0549-2024
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Product quantity
- 8 bottles
- Termination date
- Jul 1, 2024
- Reason for recall
- Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed to one medical facility.
- Recall initiation date
- May 31, 2024
- Initial firm notification
- Letter
- Center classification date
- Jun 10, 2024