The Recall Desk
ModerateFDA (Drugs)·D-0802-2017·Announced 2017-05-31

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.

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, 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

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.

See all 60 products in this recall →