Advanced Pharma Recalls Ondansetron HCl Due to Latex Labeling Defect
Advanced Pharma Inc. is recalling all strengths and dosage forms of Ondansetron HCl because the product labeling may not adequately disclose the presence of synthetic or natural latex.
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, which typically indicates a situation where use of the product could cause temporary or medically reversible adverse health consequences. The hazard is a labeling error regarding latex content, which is a known allergen, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Advanced Pharma Inc. has initiated a recall of Ondansetron HCl, a prescription-only medication. The recall covers all strengths, all dosage forms, and all packaging configurations of the product. The distribution of the affected units was nationwide across the United States.
The reason for the recall is a labeling defect. The product may contain synthetic latex and/or natural latex, but the labeling does not properly classify or disclose this information. This omission is significant for patients with latex allergies, as the lack of clear labeling prevents them from making informed decisions about their medication.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatments. The recall is limited to the labeling issue regarding latex content.
The recalled product
- Product
- Ondansetron 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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