Advanced Pharma Recalls Amiodarone Due to Potential Latex Content
Advanced Pharma Inc. is recalling all Amiodarone products due to a labeling issue regarding potential synthetic or natural latex content.
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 but involves a labeling error regarding latex content without reported injuries or illnesses, fitting the criteria for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
Advanced Pharma Inc. has initiated a recall of Amiodarone, covering all strengths, dosage forms, and packaging. The product is prescription-only and was distributed nationwide in the United States. The recall involves all lots within their expiration dates.
The reason for the recall is a labeling deficiency where the product may contain synthetic latex and/or natural latex, but this information is not properly classified or disclosed. This issue falls under the category of 'Not Elsewhere Classified' labeling errors.
Healthcare providers and patients should be aware of this potential latex content. Individuals with latex allergies should consult their healthcare provider regarding the use of this medication. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Amiodarone all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Cardiovascular
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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