Salsalate Tablets, USP, 750 mg, packaged in a) 100 count bottles (NDC 42937-704-10); b) 500 count bottles (NDC 42937-704-18); and c) 1000 count bottles (NDC 42937-704-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830.

Recall Number: D-0166-2017

Firm: Nationwide Laboratories, LLC

Classification: Class II

Status: Terminated

Report Date: 20161207

Initiation Date: 20161028

Termination Date: 20180517

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

Salsalate Tablets, USP, 750 mg, packaged in a) 100 count bottles (NDC 42937-704-10); b) 500 count bottles (NDC 42937-704-18); and c) 1000 count bottles (NDC 42937-704-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830.