Reported Dec 7, 2016 · Terminated
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel…
Burel Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Burel Pharmaceuticals Inc · 199 Interstate Dr Ste N · Richland, MS · 39218-9433
Is this the product you have?
- Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only
- Manufactured forBurel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10
- Lot codes and dates
Lot #: 28181601EXP 1/1828181603EXP 5/1828181604EXP 5/1828181605EXP 5/1828181606EXP 6/1828181607EXP 5/18
- Amount recalled
- 35,149 bottles
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
This product could cause temporary or reversible health problems — stop using it.
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