Advanced Pharma Recalls Bumetanide Due to Latex Labeling Deficiency
Advanced Pharma Inc. is recalling all strengths and dosage forms of Bumetanide because the product labeling fails to disclose that it may contain synthetic or natural latex.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 involves a labeling error regarding latex content, which fits the rubric criteria for minor labeling errors or low-risk contamination without reported injuries.
Plain-English summary
Advanced Pharma Inc. has initiated a recall of Bumetanide, a prescription-only medication. The recall covers all strengths, all dosage forms, and all packaging of the product. The distribution pattern for the affected units is U.S. Nationwide.
The reason for the recall is a labeling deficiency. The product labeling does not properly disclose that the products may contain synthetic latex and/or natural latex. This information is critical for patients with latex allergies.
Consumers and healthcare providers should stop using the affected Bumetanide products and contact their healthcare provider or pharmacist for guidance. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Bumetadine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Prescription Medication
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 (1)
- all lots within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 60 recalled by Advanced Pharma 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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