Advanced Pharma Recalls Standard Starter TPN Due to Latex Labeling
Advanced Pharma Inc. is recalling Standard 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, but the source text identifies the issue as a labeling error regarding latex content without reporting specific injuries or illnesses, fitting the criteria for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
Advanced Pharma Inc. has issued a recall for Standard Starter TPN, including all strengths, dosage forms, and packaging. The recall covers all lots of the product, which is distributed nationwide in the United States. The product is prescription-only and was distributed by Avella of Houston in Houston, TX.
The reason for the recall is a labeling issue where the products may contain synthetic latex and/or natural latex. This classification is designated as 'Not Elsewhere Classified' by the FDA. The recall is classified as Class II by the agency.
Consumers and healthcare providers should check their inventory for Standard Starter TPN products from Advanced Pharma Inc. If you have questions about this recall or the latex content of the product, contact the recalling firm or your healthcare provider.
The recalled product
- Product
- Standard 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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