May 2024 FDA Recall Phenazopyridine Hydrochloride by Winder Laboratories, Llc
D-0545-2024 - Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
This Class II drug recall was voluntarily initiated by Winder Laboratories, Llc on May 28, 2024 for the product Phenazopyridine Hydrochloride. The FDA reported the reason for recall as product mix up. a bottle of phenazopyridine hcl tablets usp 100 mg contained phenobarbital tablets 16.2 mg.. The product was distributed Nationwide and the recall is currently completed.
Recall Number: D-0545-2024
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
05-28-2024
06-19-2024
473 cases (5676 Bottles)
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Winder Laboratories, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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,
Batch or Lot Expiration Information
Lot# : 1142404 Exp. Date 02/27/2027
