Advanced Pharma Recalls Sufentanil Citrate Due to Latex Labeling Defect
Advanced Pharma Inc. is recalling all lots of Sufentanil Citrate because the product may contain latex, which is not currently disclosed on the label.
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 and involves a labeling error regarding latex content, which fits the rubric criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Advanced Pharma Inc. has initiated a recall of Sufentanil Citrate in all strengths, dosage forms, and packaging. The recall is being conducted because the product may contain synthetic latex and/or natural latex, a fact that is not currently classified or disclosed in the product labeling.
The recall covers all lots of the medication, which is distributed nationwide in the United States. Sufentanil Citrate is a prescription-only medication.
Patients and healthcare providers should be aware that the product may contain latex components. Individuals with known latex allergies should consult their healthcare provider regarding the use of this medication and potential alternatives.
The recalled product
- Product
- Sufentanil Citrate 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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