Why it was recalled
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Product description
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 PHARMACEUTICALS, Richland, MS --- NDC 35573-301-90
Lot numbers, UPCs & expiration codes
LOT # 29001501, EXP 07/17
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0155-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 24, 2016
- FDA report date
- Dec 7, 2016
- Quantity
- 2861 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Burel Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0155-2017, exactly as published.
Show all FDA fields
- City
- Richland
- State
- MS
- Status
- Terminated
- Country
- United States
- Event ID
- 75566
- Address
- 199 Interstate Dr Ste N
- Code information
- LOT # 29001501, EXP 07/17
- Postal code
- 39218-9433
- Report date
- Dec 7, 2016
- Product type
- Drugs
- Recall number
- D-0155-2017
- Classification
- Class II
- Recalling firm
- Burel Pharmaceuticals Inc
- Product quantity
- 2861 bottles
- Termination date
- Aug 14, 2017
- Reason for recall
- CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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 PHARMACEUTICALS, Richland, MS --- NDC 35573-301-90
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 24, 2016
- Initial firm notification
- Center classification date
- Nov 29, 2016