Advanced Pharma Recalls Fentanyl Citrate Due to Latex Labeling Deficiency
Advanced Pharma Inc. is recalling all lots of Fentanyl Citrate because the product labeling does not indicate that it 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 and involves a labeling error regarding potential latex content. No illnesses or injuries are reported in the source text, and the hazard is theoretical for those without latex allergies, fitting the criteria for a moderate severity score.
Plain-English summary
Advanced Pharma Inc. has initiated a recall of Fentanyl Citrate in all strengths, dosage forms, and packaging. The recall covers all lots distributed nationwide in the United States. The product is prescribed only and is manufactured by Advanced Pharma Inc.
The reason for the recall is a labeling deficiency. The product may contain synthetic latex and/or natural latex, but this information is not currently indicated on the product labeling. This omission may pose a risk to patients with latex allergies.
Healthcare providers and patients should be aware of this potential latex content. Individuals with known latex allergies should consult their healthcare provider regarding the use of this medication. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Fentanyl Citrate all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Opioid Analgesic
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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