Home / Recalls / Winder Laboratories, LLC / D-0545-2024

D-0545-2024 Class II

Recalled by Winder Laboratories, LLC — Winder, GA

Recall Details

Product Type: Drugs
Report Date: June 19, 2024
Initiation Date: May 28, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 473 cases (5676 Bottles)

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,

Reason for Recall

Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.

Distribution Pattern

Nationwide within the United States

Code Information

Lot#: 1142404 Exp. Date 02/27/2027