Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: 28161601, EXP 1/18; 28161603, EXP 5/18; and 28161604, EXP 6/18
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Burel Pharmaceuticals Inc
- Reason for Recall:
- CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10
Product Codes/Lot Numbers:
Lot #: 28161601, EXP 1/18; 28161603, EXP 5/18; and 28161604, EXP 6/18
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0161-2017
Related Recalls
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10
Burel Pharmaceuticals
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures