The Recall Desk

Manufacturer

Burel Pharmaceuticals Inc

8 recalls in our database name Burel Pharmaceuticals Inc as the manufacturing or recalling firm.

What the numbers show

Total
8
Critical
0
Severe
0
Most recent
2016-12-07

Of the 8 recalls from Burel Pharmaceuticals Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–8 of 8

  • ModerateFDA (Drugs)·D-0159-2017·2016-12-07

    Burel Pharmaceuticals Recalls AZUPHEN MB Urinary Antiseptic Capsules

    Burel Pharmaceuticals is recalling AZUPHEN MB Urinary Antiseptic Capsules due to manufacturing deviations that may cause assay or content uniformity failures.

    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 -
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0160-2017·2016-12-07

    Burel Pharmaceuticals Recalls Indiomin MB Capsules Due to Manufacturing Deficiencies

    Burel Pharmaceuticals is recalling 795 bottles of Indiomin MB capsules due to manufacturing deviations that may cause assay or content uniformity failures.

    Product
    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, Rx only, Manufactured for: BUREL PHARMACEUTICALS, NDC 35573-315-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0162-2017·2016-12-07

    Burel Pharmaceuticals Recalls Phenazopyridine Hydrochloride Tablets Due to Manufacturing Deficiencies

    Burel Pharmaceuticals is recalling specific lots of Phenazopyridine Hydrochloride Tablets due to manufacturing deviations that may result in assay or content uniformity failures.

    Product
    Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0157-2017·2016-12-07

    Burel Pharmaceuticals Recalls Uramit MB Urinary Antiseptic Capsules

    Burel Pharmaceuticals is recalling Uramit MB Urinary Antiseptic Capsules due to manufacturing deviations that may cause assay or content uniformity failures.

    Product
    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 --
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0156-2017·2016-12-07

    Burel Pharmaceuticals Recalls UROLET MB Tablets Due to Manufacturing Deficiencies

    Burel Pharmaceuticals is recalling UROLET MB Urinary Antiseptic tablets because manufacturing deficiencies may cause the product to fail potency or uniformity tests.

    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 3557
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0161-2017·2016-12-07

    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.

    Product
    Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0155-2017·2016-12-07

    Burel Recalls Hyolev MB Urinary Antiseptic Tablets Due to Manufacturing Deficiencies

    Burel Pharmaceuticals is recalling 2,861 bottles of Hyolev MB Urinary Antiseptic Tablets due to manufacturing deviations that may cause assay or content uniformity failures.

    Product
    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 Monobasic 40.8 mg, 90 count bottles, Rx only, Manufactured for: BUREL PHARMACEUT
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0158-2017·2016-12-07

    Burel Pharmaceuticals Recalls UROPHEN MB Urinary Antiseptic Tablets

    Burel Pharmaceuticals is recalling UROPHEN MB Urinary Antiseptic Tablets due to manufacturing deviations that may cause assay or content uniformity failures.

    Product
    UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylate 36 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-30
    Category
    Drug
    Distribution
    Distributed nationwide