US Drug Recall Register
Class II · Moderate risk Terminated Initiated Oct 28, 2016 (10 years ago)

Salsalate Tablets

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

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.

Recalling firm
Nationwide Laboratories, LLC
NDC code
42937-703-18
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0165-2017

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.