Advanced Pharma Recalls Ropivacaine HCl Injection Due to Latex Labeling
Advanced Pharma Inc. is recalling Ropivacaine HCl in 0.9% Sodium Chloride because the product may contain synthetic or natural latex, which is not currently classified in the 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, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling error regarding latex content, which fits the 'Moderate' criteria for minor labeling errors or low-risk contamination without reported severe injuries.
Plain-English summary
Advanced Pharma Inc. has initiated a recall of Ropivacaine HCl in 0.9% Sodium Chloride, available in all strengths, dosage forms, and packaging. The product is prescription-only and was distributed nationwide in the United States. The recall covers all lots of the medication.
The reason for the recall is a labeling issue where the product may contain synthetic latex and/or natural latex, a condition categorized as 'Not Elsewhere Classified.' This labeling deficiency poses a potential risk to patients with latex allergies.
Healthcare providers and patients should discontinue use of the affected Ropivacaine HCl products and contact Advanced Pharma Inc. for further instructions or returns.
The recalled product
- Product
- Ropivacaine HCl in 0.9% Sodium Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injection
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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