FDA Drug recall D-0162-2017
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS…
- FDA Drug
- Class II
- terminated
- Published 2016-12-07
On 2016-12-07 the FDA classified a Class II recall of Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS… by Burel Pharmaceuticals, citing CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0162-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-24 |
| Published | 2016-12-07 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Burel Pharmaceuticals |
| Distribution | US |
Product
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10
Reason
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Identifiers
| code_info | Lot #: 28181601, EXP 1/18; 28181603, EXP 5/18; 28181604, EXP 5/18; 28181605, EXP 5/18; 28181606, EXP 6/18; 28181607, EXP 5/18 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0162-2017%22
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