Recalls / Class II
Class IID-0162-2017
Product
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10
- Affected lot / 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
Why it was recalled
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Recalling firm
- Firm
- Burel Pharmaceuticals Inc
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 199 Interstate Dr Ste N, Richland, Mississippi 39218-9433
Distribution
- Quantity
- 35,149 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-10-24
- FDA classified
- 2016-11-29
- Posted by FDA
- 2016-12-07
- Terminated
- 2017-08-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0162-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.