Advanced Pharma Recalls Vancomycin HCl Due to Latex Labeling Defect
Advanced Pharma Inc. is recalling all lots of Vancomycin HCl because the product may contain latex but lacks appropriate labeling.
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.
Plain-English summary
Advanced Pharma Inc. is voluntarily recalling all strengths, dosage forms, and packaging of Vancomycin HCl, a prescription-only medication. The recall is being conducted because the product may contain synthetic latex and/or natural latex, but this information is not properly classified or labeled on the product.
The recall covers all lots of the medication distributed nationwide in the United States. The specific hazard is a labeling issue where the presence of latex is not clearly identified, which poses a risk to patients with latex allergies.
Consumers and healthcare providers should stop using the recalled Vancomycin HCl products and contact their healthcare provider or pharmacist for guidance on alternative treatments or further instructions.
The recalled product
- Product
- Vancomycin HCl 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
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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