# FDA recall D-0159-2017

> **Burel Pharmaceuticals Inc** · Class II · drug recall initiated 2016-10-24.

## Product

AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains:  Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-314-10

## Reason for recall

CGMP Deviations; deficiencies at the manufacturer  may result in assay or content uniformity failures

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0159-2017
- **Recalling firm:** Burel Pharmaceuticals Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-10-24
- **Report date:** 2016-12-07
- **Termination date:** 2017-08-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Richland, MS, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0159-2017

## Citation

> AI Analytics. FDA recall D-0159-2017. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0159-2017. Source: US FDA. Licensed CC0.

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