The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0166-2017·Announced 2016-12-07

Nationwide Laboratories Recalls Salsalate Tablets Due to Manufacturing Deviations

Nationwide Laboratories is recalling Salsalate Tablets, 750 mg, because they were manufactured under practices that may result in assay or content uniformity failures.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential assay or content uniformity failures without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Nationwide Laboratories, LLC is recalling Salsalate Tablets, USP, 750 mg. The affected product is packaged in 100, 500, and 1000 count bottles and is available by prescription only. The recall involves 2,514,500 tablets distributed nationwide in the USA and Puerto Rico.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the tablets were manufactured under practices which may result in assay or content uniformity failures. This means the amount of active ingredient in the tablets may not be consistent or accurate.

Patients who have been prescribed Salsalate Tablets, USP, 750 mg, should contact their healthcare provider or pharmacist for guidance on how to proceed. The specific lot numbers and expiration dates are listed in the structured product information provided by the FDA.

The recalled product

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.
Manufacturer
Nationwide Laboratories, LLC
Category
Drug — Prescription Medication
Hazard
Affected units
2,514,500

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • Lot #: a) 28141502
  • 28141503
  • 28141504
  • 28141505
  • 28141506
  • Exp 03/17
  • 28141507
  • Exp 09/17
  • 28141508
  • 28141510
  • 28141511
  • Exp 10/17
  • b) 28141502
  • c) 28141501
  • 28141502

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 4 recalled by Nationwide Laboratories, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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