Recalling firm
Winder Laboratories, LLC
Product type
Drug
Status
Completed
Report date
2024-06-19
Distribution
Nationwide within the United States
Firm state
GA
Product quantity
473 cases (5676 Bottles)
Initiated by
Voluntary: Firm initiated
Reason for recall
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
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,
Code / lot info
Lot#: 1142404 Exp. Date 02/27/2027
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.