Phenazopyridine Hydrochloride Tablets recall: CGMP Deviations
Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC…
Why was Phenazopyridine Hydrochloride Tablets recalled?
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 28161601, EXP 1/18; 28161603, EXP 5/18; and 28161604, EXP 6/18
- Product
- Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC…
- Recalling firm
- Burel Pharmaceuticals Inc
- Quantity
- 17,788 bottles
- Distribution
- Nationwide
- Recall date
- December 7, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)