Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

URAMIT MB URINARY ANTISEPTIC Capsules Recalled by Burel Pharmaceuticals Inc Due to CGMP Deviations; deficiencies at the manufacturer may result...

Date: October 24, 2016
Company: Burel Pharmaceuticals Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Burel Pharmaceuticals Inc directly.

Affected Products

URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 118 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 35573-300-10

Quantity: 2,771 bottles

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Burel Pharmaceuticals Inc

Burel Pharmaceuticals Inc has 8 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report