Nationwide Laboratories, LLC recalls Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-703-18); b) 100 count bottles (NDC 42937-703
Recalled December 7, 2016 · FDA recall D-0165-2017 · Nationwide Laboratories
Hazard
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures. · FDA Class II
Units
2,882,661 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
Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-703-18); b) 100 count bottles (NDC 42937-703-10); and c) 1000 count bottles (NDC 42937-703-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830.
Manufacturer(s)
Nationwide Laboratories, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →