Nationwide Laboratories, LLC recalls Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratorie
Recalled December 7, 2016 · FDA recall D-0167-2017 · Nationwide Laboratories
Hazard
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures. · FDA Class II
Units
6,333,669 tablets
Sold at
Nationwide in USA and Puerto Rico
Description
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Product
Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-701-10.
Manufacturer(s)
Nationwide Laboratories, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →