Advanced Pharma Recalls Ketamine HCl for Potential Latex Content
Advanced Pharma Inc. is recalling all lots of Ketamine HCl because the product may contain synthetic or natural latex.
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, but the hazard is a labeling issue regarding potential latex content without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Advanced Pharma Inc. is recalling all strengths, dosage forms, and packaging of Ketamine HCl, a prescription-only medication. The recall is being conducted because the products may contain synthetic latex and/or natural latex.
The recall covers all lots of the product and is distributed nationwide in the United States. The specific reason for the latex presence is not detailed in the source text, but the labeling issue is classified as 'Not Elsewhere Classified.'
Consumers and healthcare providers should discontinue use of the affected products and contact their healthcare provider or the recalling firm for further instructions. No specific lot numbers are provided, so all inventory of this product should be reviewed.
The recalled product
- Product
- Ketamine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Prescription Medication
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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