FDA Drug recall D-0165-2017
Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-703-18)
- FDA Drug
- Class II
- terminated
- Published 2016-12-07
On 2016-12-07 the FDA classified a Class II recall of Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-703-18) by Nationwide Laboratories, citing CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0165-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-28 |
| Published | 2016-12-07 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Nationwide Laboratories |
| Distribution | US |
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
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Identifiers
| code_info | Lot #: a) 28121501, 28121502, 28121503, 28121504, Exp 03/17; 28121505, Exp 06/17; 28121506, 28121507, Exp 09/17; b) 28…Lot #: a) 28121501, 28121502, 28121503, 28121504, Exp 03/17; 28121505, Exp 06/17; 28121506, 28121507, Exp 09/17; b) 28121503, 28121504, Exp 03/17; 28121505, Exp 06/17; 28121506, 28121507, Exp 09/17; c) 28121505, Exp 06/17; 28121506, 28121507, Exp 09/17 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0165-2017%22
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