Burel Pharmaceuticals Inc
Complete recall history across all FDA and CPSC categories — 8 total recalls
Burel Pharmaceuticals Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (8)
FDA drug safety enforcement actions by Burel Pharmaceuticals Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| Oct 24, 2016 | UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: M... | CGMP Deviations; deficiencies at the manufacturer may result in assay or con... | Class II |
| Oct 24, 2016 | UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.... | CGMP Deviations; deficiencies at the manufacturer may result in assay or con... | Class II |
| Oct 24, 2016 | Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains... | CGMP Deviations; deficiencies at the manufacturer may result in assay or con... | Class II |
| Oct 24, 2016 | Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration con... | CGMP Deviations; deficiencies at the manufacturer may result in assay or con... | Class II |
| Oct 24, 2016 | URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 11... | CGMP Deviations; deficiencies at the manufacturer may result in assay or con... | Class II |
| Oct 24, 2016 | Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx onl... | CGMP Deviations; deficiencies at the manufacturer may result in assay or con... | Class II |
| Oct 24, 2016 | AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 1... | CGMP Deviations; deficiencies at the manufacturer may result in assay or con... | Class II |
| Oct 24, 2016 | Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx onl... | CGMP Deviations; deficiencies at the manufacturer may result in assay or con... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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