The Recall Desk
ModerateFDA (Drugs)·D-0801-2017·Announced 2017-05-31

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.

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 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

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.

See all 60 products in this recall →