Advanced Pharma Recalls Cardioplegic Solution for Latex Labeling Defect
Advanced Pharma Inc. is recalling Cardioplegic Solution Maintenance due to a labeling error regarding potential latex content.
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 error regarding latex content, which fits the rubric for moderate severity involving minor labeling errors or low-risk issues.
Plain-English summary
Advanced Pharma Inc. is voluntarily recalling all strengths, dosage forms, and packaging of Cardioplegic Solution Maintenance. The recall is initiated because the product labeling does not adequately indicate that the products may contain synthetic latex and/or natural latex.
The recall covers all lots within their expiration dates and is distributed nationwide in the United States. The product is prescription-only and was distributed through Avella of Houston in Houston, Texas.
Healthcare providers and patients should discontinue use of the affected products and contact their healthcare provider or the recalling firm for further instructions. This recall is a labeling correction to ensure patients with latex allergies are properly informed.
The recalled product
- Product
- Cardioplegic Solution Maintenance all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Cardiac
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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