Burel Pharmaceuticals Recalls Phenazopyridine Hydrochloride Tablets Due to CGMP Deviations
Burel Pharmaceuticals is recalling 17,788 bottles of Phenazopyridine Hydrochloride Tablets due to manufacturing deviations that may cause assay or content uniformity failures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which is reasonably likely to cause temporary or medically reversible adverse health consequences. The hazard involves potential content uniformity failures, which is a moderate risk compared to critical defects like contamination or mislabeling of high-risk allergens.
Plain-English summary
Burel Pharmaceuticals, Inc. is recalling 17,788 bottles of Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles. The affected product is prescription-only and was distributed nationwide. The recall involves specific lots with expiration dates in January, May, and June 2018.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations and deficiencies at the manufacturer. These issues may result in assay or content uniformity failures, meaning the medication may not contain the correct amount of the active ingredient or may not be consistent throughout the bottle.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider for further instructions. The product should be returned to the pharmacy or point of purchase for disposal or credit.
The recalled product
- Product
- Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10
- Manufacturer
- Burel Pharmaceuticals Inc
- Category
- Drug — Prescription Medication
- Affected units
- 17,788
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: 28161601
- EXP 1/18
- 28161603
- EXP 5/18
- and 28161604
- EXP 6/18
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Burel Pharmaceuticals Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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