Advanced Pharma Recalls TPN Products Due to Latex Labeling Defect
Advanced Pharma Inc. is recalling TPN products because they may contain latex but lack 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. is recalling ADD HEPARIN PF 50 Units ONLY TO TPN products in all strengths, dosage forms, and packaging. The recall is limited to products distributed nationwide in the United States.
The recall was initiated due to a labeling defect. The source text indicates that the products may contain synthetic latex and/or natural latex, but this information is not properly classified or labeled. This omission poses a risk to individuals with latex allergies.
Consumers and healthcare providers should discontinue use of the affected products and contact the manufacturer or their healthcare provider for further instructions. The recall covers all lots of the specified product.
The recalled product
- Product
- ADD HEPARIN PF 50 Units ONLY TO 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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