FDA-Drug2016-12-07Class II

Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-702-10.

Nationwide Laboratories, LLC
Hazard

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

Sold states
Nationwide in USA and Puerto Rico
Affected count
5,786,653 tablets
Manufactured in
33 Wood Ave S Ste 600, Iselin, NJ, United States
Products
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-702-10.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0168-2017

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