The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0161-2017·Announced 2016-12-07

Burel Pharmaceuticals Recalls Phenazopyridine Hydrochloride Tablets Due to CGMP Deviations

Burel Pharmaceuticals is recalling 17,788 bottles of Phenazopyridine Hydrochloride Tablets due to manufacturing deviations that may cause 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 reasonably likely to cause temporary or medically reversible adverse health consequences. The hazard involves potential content uniformity failures, which is a moderate risk compared to critical defects like contamination or mislabeling of high-risk allergens.

Plain-English summary

Burel Pharmaceuticals, Inc. is recalling 17,788 bottles of Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles. The affected product is prescription-only and was distributed nationwide. The recall involves specific lots with expiration dates in January, May, and June 2018.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations and deficiencies at the manufacturer. These issues may result in assay or content uniformity failures, meaning the medication may not contain the correct amount of the active ingredient or may not be consistent throughout the bottle.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider for further instructions. The product should be returned to the pharmacy or point of purchase for disposal or credit.

The recalled product

Product
Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10
Manufacturer
Burel Pharmaceuticals Inc
Category
Drug — Prescription Medication
Hazard
Affected units
17,788

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 (6)

  • Lot #: 28161601
  • EXP 1/18
  • 28161603
  • EXP 5/18
  • and 28161604
  • EXP 6/18

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Burel Pharmaceuticals Inc 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 8 products in this recall →

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