FDA recall D-0545-2024

Winder Laboratories, LLC · Class II · 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,

Reason for recall

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

Distribution

Nationwide within the United States

Key facts

Status: Completed
Initiation date: 2024-05-28
Report date: 2024-06-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Winder, GA, United States

Primary source

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