Advanced Pharma Recalls Gentamicin Sulfate for Latex Labeling Defect
Advanced Pharma Inc. is recalling all Gentamicin Sulfate products due to a labeling error regarding potential latex content.
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 due to a labeling error regarding latex content, which fits the rubric criterion for minor labeling errors or low-risk contamination.
Plain-English summary
Advanced Pharma Inc. is voluntarily recalling all strengths, dosage forms, and packaging of Gentamicin Sulfate, a prescription-only medication. The recall is being conducted by the U.S. Food and Drug Administration (FDA) under recall number D-0820-2017.
The reason for the recall is a labeling defect. The products may contain synthetic latex and/or natural latex, but this information was not properly classified or labeled. This is a Class II recall, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
The recall covers all lots within their expiration dates and is distributed nationwide in the United States. Patients and healthcare providers should stop using the recalled products and contact their healthcare provider for alternative treatment options. Consumers should not attempt to dispose of prescription medications without professional guidance.
The recalled product
- Product
- Gentamicin Sulfate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Antibiotic
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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