FDA-Drug2016-12-07Class II

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.

Nationwide Laboratories, LLC
Hazard

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

Sold states
Nationwide in USA and Puerto Rico
Affected count
2,514,500 tablets
Manufactured in
33 Wood Ave S Ste 600, Iselin, NJ, United States
Products
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.

Official notice

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

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