Advanced Pharma Recalls Ropi Epi Clon Injection Due to Latex Labeling
Advanced Pharma Inc. is recalling Ropi/ Epi/ Clon PeriCapsular injection 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 and involves a labeling issue regarding potential latex content, which fits the criteria for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
Advanced Pharma Inc. is voluntarily recalling Ropi/ Epi/ Clon PeriCapsular injection, all strengths, dosage forms, and packaging. The recall is being conducted because the product may contain synthetic latex and/or natural latex, but this information is not properly classified in the labeling.
The recall covers all lots of the product, which is distributed nationwide in the United States. The product is prescription-only and is manufactured by Advanced Pharma Inc. in Houston, Texas.
Consumers and healthcare providers should discontinue use of the recalled product and contact their healthcare provider for guidance. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Ropi/ Epi/ Clon PeriCapsular injection 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
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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