Advanced Pharma Recalls Dexmedetomidine HCl Due to Latex Labeling
Advanced Pharma Inc. is recalling all lots of Dexmedetomidine HCl because the product may contain synthetic or natural latex, which is not currently labeled.
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, but the source text does not report any hospitalizations or specific injuries, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
Advanced Pharma Inc. is voluntarily recalling all strengths, dosage forms, and packaging of Dexmedetomidine HCl. The recall is being conducted because the product may contain synthetic latex and/or natural latex, and this information is not currently included on the product labeling.
The recall covers all lots within their expiration dates and is distributed nationwide in the United States. Dexmedetomidine HCl is a prescription-only medication manufactured by Advanced Pharma Inc. and distributed by Avella of Houston, located in Houston, Texas.
Healthcare providers and patients should check their inventory of Dexmedetomidine HCl for the presence of latex components. Individuals with a known latex allergy should consult their healthcare provider before using any remaining stock of this medication. The recall is classified as FDA Class II, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Dexmedetomidine 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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