Drug product
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,
D-0545-2024
Product summary
- Event
- Event 94727
- Status
- Completed
- Classification
- Class II
- Quantity
- 473 cases (5676 Bottles)
- Official record key
drug-enforcement:D-0545-2024
Official wording
Reason: Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Code information: Lot#: 1142404 Exp. Date 02/27/2027
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.