Advanced Pharma Recalls Nicardipine HCl Due to Latex Labeling
Advanced Pharma Inc. is recalling all lots of Nicardipine HCl because the product may contain latex but 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 due to a labeling error regarding latex content, which fits the rubric for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
Advanced Pharma Inc. is recalling all strengths, dosage forms, and packaging of Nicardipine HCl. The recall is due to a labeling issue where the product may contain synthetic latex and/or natural latex, but this information is not properly classified or indicated on the label.
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 by Avella of Houston in Houston, TX.
Patients and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatments. The FDA classifies this recall as Class II, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Nicardipine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Prescription Medication
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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