The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0168-2017·Announced 2016-12-07

Nationwide Laboratories Recalls Phenazopyridine Hydrochloride Tablets Due to CGMP Deviations

Nationwide Laboratories LLC is recalling Phenazopyridine Hydrochloride Tablets, 200 mg, 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 typically involves a temporary or medically reversible adverse health consequence. The hazard is a potential manufacturing defect (assay/content uniformity) without reported illnesses or injuries, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Nationwide Laboratories LLC is recalling Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only. The affected product is manufactured for Nationwide Laboratories LLC in Iselin, New Jersey, and carries the NDC 42937-702-10. The recall involves 5,786,653 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.

Affected lots include 28181501, 28181502 (Exp 03/17); 28181503, 28181504 (Exp 08/17); 28181505, 28181506 (Exp 09/17); and 28181601 (Exp 01/18). Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or healthcare provider for disposal or replacement.

The recalled product

Product
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-702-10.
Manufacturer
Nationwide Laboratories, LLC
Category
Drug — Prescription Medication
Hazard
Affected units
5,786,653

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 (11)

  • Lot #: 28181501
  • 28181502
  • Exp 03/17
  • 28181503
  • 28181504
  • Exp 08/17
  • 28181505
  • 28181506
  • Exp 09/17
  • 28181601
  • 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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