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Burel Pharmaceuticals Inc

Burel Pharmaceuticals Inc Recalls

All product recalls associated with Burel Pharmaceuticals Inc.

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Recall Summary

Total Recalls

8

Past Year

0

Class I (Serious)

0

Most Recent

Oct 2016

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–8 of 8 recalls

Azuphen MB Urinary Antiseptic Capsules (Burel Pharmaceuticals) – CGMP Manufacturing Risk (2016)

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

Class IIModerate

FDAOct 24, 2016Nationwide• Burel Pharmaceuticals Inc

Phenazopyridine Hydrochloride 200mg (Burel Pharmaceuticals) – CGMP Manufacturing Risk (2016)

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

Class IIModerate

FDAOct 24, 2016Nationwide• Burel Pharmaceuticals Inc

Indiomin MB Urinary Antiseptic Capsules (Burel Pharmaceuticals) – CGMP Manufacturing Risk (2016)

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

Class IIModerate

FDAOct 24, 2016Nationwide• Burel Pharmaceuticals Inc

Hyolev MB Urinary Antiseptic Tablets (Burel Pharmaceuticals) – CGMP Manufacturing Risk (2016)

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

Class IIModerate

FDAOct 24, 2016Nationwide• Burel Pharmaceuticals Inc

Uramit MB Urinary Antiseptic Capsules (Burel Pharmaceuticals) – CGMP Manufacturing Risk (2016)

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

Class IIModerate

FDAOct 24, 2016Nationwide• Burel Pharmaceuticals Inc

Phenazopyridine Hydrochloride 100mg (Burel Pharmaceuticals) – CGMP Manufacturing Risk (2016)

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

Class IIModerate

FDAOct 24, 2016Nationwide• Burel Pharmaceuticals Inc

Urolet MB Urinary Antiseptic Tablets (Burel Pharmaceuticals) – CGMP Manufacturing Risk (2016)

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

Class IIModerate

FDAOct 24, 2016Nationwide• Burel Pharmaceuticals Inc

Urophen MB Urinary Antiseptic Tablets (Burel Pharmaceuticals) – CGMP Manufacturing Risk (2016)

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

Class IIModerate

FDAOct 24, 2016Nationwide• Burel Pharmaceuticals Inc