Advanced Pharma Recalls Bupivacaine HCl Due to Latex Labeling Defect
Advanced Pharma Inc. is recalling Bupivacaine HCl in 0.9% Sodium Chloride because the product may contain synthetic or natural latex, which is not properly labeled.
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, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a labeling error regarding latex content, which is a known allergen but does not involve a high-risk pathogen or structural defect.
Plain-English summary
Advanced Pharma Inc. has initiated a recall of Bupivacaine 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 defect. The source text indicates that the products may contain synthetic latex and/or natural latex, but this information is not appropriately classified or labeled. This poses a risk to individuals with latex allergies.
Consumers and healthcare providers should stop using the affected Bupivacaine HCl products and contact their pharmacist or the recalling firm for further instructions. Patients with known latex allergies should be particularly cautious and consult their healthcare provider regarding alternative treatments.
The recalled product
- Product
- Bupivacaine 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 — Injectable Anesthetic
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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