# FDA recall D-0165-2017

> **Nationwide Laboratories, LLC** · Class II · drug recall initiated 2016-10-28.

## Product

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.

## 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

- **Recall number:** D-0165-2017
- **Recalling firm:** Nationwide Laboratories, LLC
- **Classification:** Class II
- **Product type:** drug
- **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

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0165-2017

## Citation

> AI Analytics. FDA recall D-0165-2017. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0165-2017. Source: US FDA. Licensed CC0.

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