Advanced Pharma Recalls 0.9% Sodium Chloride Slip Tip for Latex Labeling
Advanced Pharma Inc. is recalling 0.9% Sodium Chloride Slip Tip products because they may contain 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 issues or low-risk contamination.
Plain-English summary
Advanced Pharma Inc. is recalling 0.9% Sodium Chloride Slip Tip products, including 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, which is not otherwise classified in the source text.
The affected products are prescription-only and were distributed nationwide in the United States. The recall covers all lots within their expiration dates.
Consumers and healthcare providers should stop using these products and contact Advanced Pharma Inc. for further instructions or a replacement.
The recalled product
- Product
- 0.9% Sodium Chloride Slip Tip all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — IV Fluids
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 within expiry
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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