Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10
Reported: December 7, 2016 Initiated: October 24, 2016 #D-0162-2017
Product Description
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10
Reason for Recall
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Details
- Recalling Firm
- Burel Pharmaceuticals Inc
- Units Affected
- 35,149 bottles
- Distribution
- Nationwide
- Location
- Richland, MS
Frequently Asked Questions
What product was recalled? ▼
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10. Recalled by Burel Pharmaceuticals Inc. Units affected: 35,149 bottles.
Why was this product recalled? ▼
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 7, 2016. Severity: Moderate. Recall number: D-0162-2017.
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