Advanced Pharma Recalls NICU Starter TPN Due to Latex Labeling
Advanced Pharma Inc. is recalling NICU Starter TPN products because they may contain synthetic or natural latex without proper 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 the hazard involves a labeling error regarding latex content, which fits the criteria for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
Advanced Pharma Inc. has initiated a recall of NICU Starter TPN products, including all strengths, dosage forms, and packaging. The products are prescription-only and were distributed nationwide in the United States.
The recall was issued due to a labeling issue where the products may contain synthetic latex and/or natural latex. This classification falls under 'Not Elsewhere Classified' for labeling defects.
Healthcare providers and patients should discontinue use of the affected products and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- NICU STARTER TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
- Manufacturer
- Advanced Pharma Inc.
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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