Drug recall D-0545-2024

Class II Completed reported Jun 19, 2024

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,

Reason for recall

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

Lots and codes

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

Recall details

Recalling firm
Winder Laboratories, LLC, Winder, GA
Quantity
473 cases (5676 Bottles)
Distribution
Nationwide within the United States
Type
Voluntary: Firm initiated
Recall initiated
May 28, 2024

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