Advanced Pharma Recalls Fentanyl and Bupivacaine Products for Latex Labeling
Advanced Pharma Inc. is recalling Fentanyl Citrate and Bupivacaine HCl products because labeling may not disclose the presence of synthetic or natural latex.
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 due to a labeling error regarding latex content. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries fall under the Moderate severity category.
Plain-English summary
Advanced Pharma Inc. is recalling all strengths, dosage forms, and packaging of Fentanyl Citrate and Bupivacaine HCl products. The recall is due to a labeling issue where the products may contain synthetic latex and/or natural latex, but this information is not properly classified or disclosed on the label.
The recall covers all lots within their expiration dates and is distributed nationwide in the United States. The products are prescription-only and were distributed by Avella of Houston, located in Houston, TX.
Healthcare providers and patients should check their inventory for these products. If you have a known latex allergy, consult your healthcare provider before using any remaining stock. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Fentanyl Citrate and Bupivacaine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Injection
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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