Burel Pharmaceuticals Recalls Phenazopyridine Hydrochloride Tablets Due to Manufacturing Deficiencies
Burel Pharmaceuticals is recalling specific lots of Phenazopyridine Hydrochloride Tablets due to manufacturing deviations that may result in 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, and the hazard involves potential assay or content uniformity failures without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Burel Pharmaceuticals, Inc. is recalling Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles. The recall involves 35,149 bottles distributed nationwide. The affected lots are 28181601 (EXP 1/18), 28181603 (EXP 5/18), 28181604 (EXP 5/18), 28181605 (EXP 5/18), 28181606 (EXP 6/18), and 28181607 (EXP 5/18).
The recall is being conducted 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 check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, it should be discontinued and returned to the pharmacy or supplier for credit or replacement.
The recalled product
- Product
- Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10
- Manufacturer
- Burel Pharmaceuticals Inc
- Category
- Drug — Prescription Medication
- Affected units
- 35,149
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 (9)
- Lot #: 28181601
- EXP 1/18
- 28181603
- EXP 5/18
- 28181604
- 28181605
- 28181606
- EXP 6/18
- 28181607
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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