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Class II: temporary or reversible health riskTerminated

Burel Pharmaceuticals UROPHEN MB URINARY ANTISEPTIC Tablets Recall

UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81

Burel Pharmaceuticals Inc · Richland, MS

Risk level
Class II
Reported by FDA
Dec 7, 2016
Recall ID
D-0158-2017
Check your lot numberHow we source this data

Summary

Burel Pharmaceuticals recalled UROPHEN MB URINARY ANTISEPTIC Tablets starting Oct 24, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0158-2017 on Dec 7, 2016. Reason: CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures. Status: Terminated.

Why it was recalled

CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures

Product description

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 35573-307-10

Lot numbers, UPCs & expiration codes

LOT # 29131501, EXP 9/17

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-0158-2017
Classification
Class II
Status
Terminated
Recall initiated
Oct 24, 2016
FDA report date
Dec 7, 2016
Quantity
823 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Burel Pharmaceuticals Inc

Original FDA data

Every field from FDA enforcement report D-0158-2017, 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 # 29131501, EXP 9/17
Postal code
39218-9433
Report date
Dec 7, 2016
Product type
Drugs
Recall number
D-0158-2017
Classification
Class II
Recalling firm
Burel Pharmaceuticals Inc
Product quantity
823 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
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 35573-307-10
Distribution pattern
Nationwide
Recall initiation date
Oct 24, 2016
Initial firm notification
E-Mail
Center classification date
Nov 29, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0158-2017, published Dec 7, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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