FDA recall D-0166-2017

Product

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.

Reason for recall

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

Distribution

Nationwide in USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2016-10-28

Report date

2016-12-07

Termination date

2018-05-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Iselin, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0166-2017