Salsalate Tablets recalled over manufacturing violations

Recall date

October 28, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Nationwide Laboratories, LLC recalls Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-703-18); b) 100 count bottles (NDC 42937-70…

Recall number

D-0165-2017

FDA classification

Class II

Brand / firm

Nationwide Laboratories, LLC

Sold / distributed

Nationwide in USA and Puerto Rico

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.