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

FDA Recall #D-0167-2017 — Class II — October 28, 2016

Recall #D-0167-2017 Date: October 28, 2016 Classification: Class II Status: Terminated

Product Description

Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-701-10.

Reason for Recall

CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.

Recalling Firm

Nationwide Laboratories, LLC — Iselin, NJ

Classification

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

Product Type

Drugs

Product Quantity

6,333,669 tablets

Distribution

Nationwide in USA and Puerto Rico

Code Information

Lot #: 28161501, Exp 03/17; 28161502, 28161503, Exp 08/17; 28161601, 28161602, Exp 01/18

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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