Advanced Pharma Recalls Adenosine Due to Latex Labeling Deficiency
Advanced Pharma Inc. is recalling all lots of Adenosine 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, which typically involves situations where use of the product could cause temporary or medically reversible health consequences. The hazard is a labeling deficiency regarding latex content, which is a known allergen but does not involve a structural defect or reported serious injury in this specific notice.
Plain-English summary
Advanced Pharma Inc. is voluntarily recalling all strengths, dosage forms, and packaging of Adenosine, a prescription-only medication. The recall is being conducted because the product may contain synthetic latex and/or natural latex, but the labeling does not adequately disclose this information.
The recall covers all lots within their expiration dates and is distributed nationwide in the United States. The specific reason for the recall is classified as a labeling issue where products may contain latex without proper notification.
Consumers and healthcare providers should discontinue use of the recalled Adenosine products and contact their healthcare provider for alternative treatment options. Patients with known latex allergies should be particularly cautious and consult their medical provider regarding the use of any remaining stock.
The recalled product
- Product
- Adenosine 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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