Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Supply Disruption — Burel Pharmaceuticals Inc (Mod
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Supply Disruption — Burel Pharmaceuticals Inc (Mod is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only,; Manufacturer: Burel
| Drug name | Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, |
|---|---|
| Manufacturer | Burel Pharmaceuticals Inc |
| Recall/Disruption reason | CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Terminated |
| Record type | Enforcement/Recall |
| Recall number | D-0162-2017 |
| Initiation date | 20161024 |
| Quantity affected | 35,149 bottles |
| Dosage form | Drugs |
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