Advanced Pharma Recalls Early TPN Neonatal Products for Latex Labeling
Advanced Pharma Inc. is recalling Early TPN (Neonatal) products nationwide 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 and involves a labeling error regarding latex content, which fits the rubric for minor labeling errors or low-risk contamination.
Plain-English summary
Advanced Pharma Inc. has initiated a recall of Early TPN (Neonatal) products, including all strengths, dosage forms, and packaging. The recall is classified as Class II by the U.S. Food and Drug Administration. The products are prescription-only and were distributed nationwide.
The reason for the recall is a labeling issue where the products may contain synthetic latex and/or natural latex, which was not properly classified or disclosed. This falls under the category of 'Labeling: Not Elsewhere Classified.'
Healthcare providers and patients should check their inventory for these products. If you have questions about the recall or your specific medication, contact Advanced Pharma Inc. or your healthcare provider for guidance.
The recalled product
- Product
- Early TPN (Neonatal) all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Parenteral Nutrition
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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