UROLET MB URINARY ANTISEPTIC — Class II drug recall D-0156-2017
Terminated recall by Burel Pharmaceuticals Inc, reported 2016-12-07, distributed nationwide. CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
| Recall number | D-0156-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Burel Pharmaceuticals Inc, Richland, MS, United States |
| Recall initiated | 2016-10-24 |
| Classified | 2016-11-29 |
| Reported by FDA | 2016-12-07 |
| Terminated | 2017-08-14 |
| Distributed | Nationwide (US) |
| Quantity | 11,539 bottles |
| Reason classes | potency, cgmp |
| NDC | 35573-0302-10, 35573-0302-30 |
| Lot numbers | 28981501, 28981601, 4/18, 8/17 |
Product
UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue, 10.8 mg; Hyoscyamine Sulfate, 0.12 mg, (a) 30 count (NDC 35573-302-30) and (b) 100 count bottles (NDC 35573-302-10), Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS
Reason for recall
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0156-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.