Why it was recalled
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Product description
Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patrick Industrial Lane, Winder, GA 30680, NDC 75826-114-10,
Lot numbers, UPCs & expiration codes
Lot#: 1142404 Exp. Date 02/27/2027
Where it was sold
Nationwide within the United States
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-0545-2024
- Classification
- Class II
- Status
- Completed
- Recall initiated
- May 28, 2024
- FDA report date
- Jun 19, 2024
- Quantity
- 473 cases (5676 Bottles)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Winder Laboratories, LLC
Original FDA data
Every field from FDA enforcement report D-0545-2024, exactly as published.
Show all FDA fields
- City
- Winder
- State
- GA
- Status
- Completed
- Country
- United States
- Event ID
- 94727
- Address
- 716 Patrick Industrial Ln
- Code information
- Lot#: 1142404 Exp. Date 02/27/2027
- Postal code
- 30680-8333
- Report date
- Jun 19, 2024
- Product type
- Drugs
- Recall number
- D-0545-2024
- Classification
- Class II
- Recalling firm
- Winder Laboratories, LLC
- Product quantity
- 473 cases (5676 Bottles)
- Reason for recall
- Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patrick Industrial Lane, Winder, GA 30680, NDC 75826-114-10,
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- May 28, 2024
- Initial firm notification
- Center classification date
- Jun 7, 2024