Advanced Pharma Recalls Fentanyl Citrate with Ropivacaine HCl Due to Latex Labeling
Advanced Pharma Inc. is recalling Fentanyl Citrate with Ropivacaine HCl because the product may contain latex and lacks 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.
Plain-English summary
Advanced Pharma Inc. is recalling Fentanyl Citrate with Ropivacaine HCl, all strengths, all dosage forms, and all packaging. The recall is being conducted because the products may contain synthetic latex and/or natural latex, but this information is not properly classified in the labeling.
The recall covers all lots within expiry and is distributed nationwide in the U.S. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions or a replacement.
The recalled product
- Product
- Fentanyl Citrate with Ropivacaine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injectable
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 within expiry.
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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