Drug recall
AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate…
FDA recall event 75566 · Class II · Burel Pharmaceuticals Inc
Key facts
| Event ID | 75566 |
|---|---|
| Recall numbers | D-0155-2017, D-0156-2017, D-0157-2017, D-0158-2017, D-0159-2017, D-0160-2017, D-0161-2017, D-0162-2017 |
| Recalling firm | Burel Pharmaceuticals Inc |
| Product type | Drugs |
| Products | 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…, Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methylene Blue 10.8 mg, Phenyl Salicylate 32.4 mg, Sodium Phosphate…, Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Methylene Blue, 10 mg; Hyoscyamine Sulfate, 0.12 mg, 100 count…, Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10, Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10 and 3 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures |
| Initiation date | Oct 24, 2016 |
| Report date | Dec 7, 2016 |
| Termination date | Aug 14, 2017 |
| City | Richland |
| State | MS |
| Country | United States |
| FEI number | 3007624504 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: