The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0167-2017·Announced 2016-12-07

Nationwide Laboratories Recalls Phenazopyridine Hydrochloride Tablets Due to Manufacturing Deviations

Nationwide Laboratories is recalling Phenazopyridine Hydrochloride Tablets due to manufacturing deviations 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, which is a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a manufacturing deviation affecting potency and uniformity, which fits the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls without reported serious injury.

Plain-English summary

Nationwide Laboratories, LLC is recalling Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles. The affected product is prescription-only and was manufactured for Nationwide Laboratories LLC in Iselin, New Jersey. The recall involves 6,333,669 tablets distributed nationwide in the USA and Puerto Rico.

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

Consumers and healthcare providers should stop using the affected lots and return them to the pharmacy or point of purchase. The affected lot numbers are 28161501 (Exp 03/17), 28161502 and 28161503 (Exp 08/17), and 28161601 and 28161602 (Exp 01/18).

The recalled product

Product
Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-701-10.
Manufacturer
Nationwide Laboratories, LLC
Category
Drug — Prescription Medication
Hazard
Affected units
6,333,669

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 (8)

  • Lot #: 28161501
  • Exp 03/17
  • 28161502
  • 28161503
  • Exp 08/17
  • 28161601
  • 28161602
  • Exp 01/18

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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