FDA-Drug2024-06-19Class II

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,

Hazard

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

Sold states
Nationwide within the United States
Affected count
473 cases (5676 Bottles)
Manufactured in
716 Patrick Industrial Ln, N/A, Winder, GA, United States
Products
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,

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0545-2024

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