Advanced Pharma Recalls TPN Neonatal Due to Latex Labeling
Advanced Pharma Inc. is recalling TPN Neonatal products because they may contain latex but lack 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, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a labeling error regarding latex content, which is a known allergen but the recall is precautionary regarding the labeling rather than a confirmed contamination event with reported injuries.
Plain-English summary
Advanced Pharma Inc. is recalling TPN Neonatal products in all strengths, dosage forms, and packaging. The recall is due to a labeling issue where the products may contain synthetic latex and/or natural latex, but this information is not properly classified or labeled.
The affected products are prescription-only and were distributed nationwide in the United States. All lots are included in this recall. This labeling deficiency poses a risk to patients with latex allergies who may be exposed to the product without being aware of the potential latex content.
Consumers and healthcare providers should stop using the affected TPN Neonatal products and contact their healthcare provider or the recalling firm for further instructions. Patients with known latex allergies should be particularly cautious and consult their medical team regarding alternative treatments.
The recalled product
- Product
- TPN Neonatal 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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