The Recall Desk
ModerateFDA (Drugs)·D-0165-2017·Announced 2016-12-07

Nationwide Laboratories Recalls Salsalate Tablets Due to Manufacturing Deviations

Nationwide Laboratories is recalling Salsalate Tablets, USP, 500 mg, because they were manufactured under practices that may result in assay or content uniformity failures.

What this means for you

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, which typically involves a reasonable probability of temporary or medically reversible health consequences. The hazard is a manufacturing deviation affecting potency, which is a moderate risk compared to acute toxicities or structural failures.

Plain-English summary

Nationwide Laboratories, LLC is recalling Salsalate Tablets, USP, 500 mg, in 100, 500, and 1000-count bottles. The affected lots are 28121501 through 28121507, with expiration dates ranging from 03/17 to 09/17. The total quantity recalled is 2,882,661 tablets.

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 medication may not contain the correct amount of the active ingredient or may not be consistent in potency across the bottle.

The product was distributed nationwide in the USA and Puerto Rico. Consumers and healthcare providers should stop using the affected Salsalate Tablets and return them to the pharmacy or contact Nationwide Laboratories for a refund or replacement.

The recalled product

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.
Manufacturer
Nationwide Laboratories, LLC
Category
Drug — Prescription Medication
Hazard
Affected units
2,882,661

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 (12)

  • Lot #: a) 28121501
  • 28121502
  • 28121503
  • 28121504
  • Exp 03/17
  • 28121505
  • Exp 06/17
  • 28121506
  • 28121507
  • Exp 09/17
  • b) 28121503
  • c) 28121505

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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