Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for:...
FDA Recall #D-0168-2017 — Class II — October 28, 2016
Product Description
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-702-10.
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
5,786,653 tablets
Distribution
Nationwide in USA and Puerto Rico
Code Information
Lot #: 28181501, 28181502, Exp 03/17; 28181503, 28181504, Exp 08/17; 28181505, 28181506, Exp 09/17; 28181601, Exp 01/18
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated