Advanced Pharma Recalls RECK PeriCapsular Injection Due to Latex Labeling
Advanced Pharma Inc. is recalling RECK PeriCapsular injection because the product may contain synthetic or natural latex, which is not clearly labeled.
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 error regarding potential latex content, which fits the criteria for moderate severity involving minor labeling errors or low-risk contamination without reported injuries.
Plain-English summary
Advanced Pharma Inc. has initiated a recall of RECK PeriCapsular injection, available in all strengths, dosage forms, and packaging. The product is prescription-only and was distributed nationwide in the United States. The recall covers all lots of the medication.
The recall was issued due to a labeling issue where the product may contain synthetic latex and/or natural latex. This information is not currently classified or clearly indicated on the product labeling, which poses a risk to individuals with latex allergies.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for guidance on alternative treatments or further instructions.
The recalled product
- Product
- RECK 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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