May 2024 FDA Recall Drug by Remedyrepack Inc.
D-0549-2024 - Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.

This Class II drug recall was voluntarily initiated by Remedyrepack Inc. on May 31, 2024 for the product Drug. The FDA reported the reason for recall as product mix up. a bottle labeled as phenazopyridine hcl tablets usp 100 mg contained phenobarbital tablets 16.2 mg.. The product was distributed in Product was distributed to one medical facility. and the recall is currently terminated.

Recall Number: D-0549-2024

Reason for Recall
Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Initiated
05-31-2024
Reported
06-19-2024
Quantity
8 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94738
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
RemedyRepack Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to one medical facility.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-01-2024
Product Description About Product Description
Full technical description of the product.
Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source NDC: 75826-0114-10 MFG: Winder Laboratories, LLC, Winder, GA

Batch or Lot Expiration Information

Lot# B2906961-042524, exp. date 02/26/2027