Advanced Pharma Recalls Heparin Sodium Due to Latex Labeling
Advanced Pharma Inc. is recalling all strengths and dosage forms of Heparin sodium because the product may contain synthetic or natural latex without proper labeling.
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 the specific hazard is a labeling error regarding latex content. Per the rubric, minor labeling errors and low-risk contamination fall under the Moderate severity category, especially in the absence of reported injuries or illnesses.
Plain-English summary
Advanced Pharma Inc. has issued a recall for Heparin sodium, available in all strengths, dosage forms, and packaging. The product is prescription-only and was distributed nationwide in the United States. The recall covers all lots within their expiration dates.
The reason for the recall is a labeling issue where the product may contain synthetic latex and/or natural latex. This classification is identified as 'Not Elsewhere Classified' by the FDA. The presence of latex is a potential concern for individuals with latex allergies, as the labeling did not adequately address this content.
Consumers and healthcare providers should discontinue the use of the recalled Heparin sodium products. Patients should consult their healthcare providers for alternative treatment options. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Heparin sodium all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Anticoagulant
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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