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Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for:...

FDA Recall #D-0162-2017 — Class II — October 24, 2016

Recall #D-0162-2017 Date: October 24, 2016 Classification: Class II Status: Terminated

Product Description

Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10

Reason for Recall

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

Recalling Firm

Burel Pharmaceuticals Inc — Richland, MS

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

35,149 bottles

Distribution

Nationwide

Code Information

Lot #: 28181601, EXP 1/18; 28181603, EXP 5/18; 28181604, EXP 5/18; 28181605, EXP 5/18; 28181606, EXP 6/18; 28181607, EXP 5/18

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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