Home / Recalls / Burel Pharmaceuticals Inc / D-0156-2017

D-0156-2017 Class II Terminated

Recalled by Burel Pharmaceuticals Inc — Richland, MS

Recall Details

Product Type
Drugs
Report Date
December 7, 2016
Initiation Date
October 24, 2016
Termination Date
August 14, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,539 bottles

Product Description

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

Distribution Pattern

Nationwide

Code Information

(a) LOT # 28981501, EXP 8/17, NDC 35573-302-30; (b) LOT # 28981501, EXP 8/17, LOT # 28981601, EXP 4/18, NDC 35573-302-10

Other recalls by Burel Pharmaceuticals Inc

  • D-0158-2017 Class II — UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 m (October 24, 2016)
  • D-0160-2017 Class II — Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: (October 24, 2016)
  • D-0155-2017 Class II — Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contai (October 24, 2016)
  • D-0159-2017 Class II — AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 (October 24, 2016)
  • D-0157-2017 Class II — URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 118 m (October 24, 2016)
  • D-0162-2017 Class II — Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, (October 24, 2016)
  • D-0161-2017 Class II — Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, (October 24, 2016)