FDAClass IIJune 19, 2024

Phenazopyridine HCl recall

Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source NDC…

Why was Phenazopyridine HCl recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source NDC…
Recalling firm
RemedyRepack Inc.
Quantity
8 bottles
Distribution
Product was distributed to one medical facility.
Recall date
June 19, 2024
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls