Advanced Pharma Recalls Lidocaine Products Due to Latex Labeling Defect
Advanced Pharma Inc. is recalling all Lidocaine products because they may contain latex but lack appropriate 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 due to a labeling error regarding latex content, which fits the rubric for minor labeling errors or low-risk contamination without reported serious injuries.
Plain-English summary
Advanced Pharma Inc. is voluntarily recalling all strengths, dosage forms, and packaging of Lidocaine products. The recall is being conducted because the products may contain synthetic latex and/or natural latex, but this information is not properly indicated on the labeling.
The affected products are prescription-only Lidocaine manufactured by Advanced Pharma Inc. and distributed nationwide in the United States. The recall covers all lots of the product. This labeling issue is classified by the FDA as Class II, indicating that use of the product could temporarily cause or contribute to reversible adverse health consequences.
Patients and healthcare providers should discontinue use of the affected Lidocaine products if they have a known latex allergy. Consumers should contact their healthcare provider for guidance on alternative treatments. The recall is limited to a labeling defect regarding latex content.
The recalled product
- Product
- Lidocaine all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Topical 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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