Advanced Pharma Recalls Betamethasone Products Due to Latex Labeling Defect
Advanced Pharma Inc. is recalling Betamethasone Sodium Phosphate & Betamethasone Acetate products because they may contain latex but lack 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 and involves a labeling error regarding latex content, which fits the rubric criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Advanced Pharma Inc. is recalling all strengths, dosage forms, and packaging of Betamethasone Sodium Phosphate & Betamethasone Acetate, a prescription-only medication. The recall is being conducted because the products may contain synthetic latex and/or natural latex, but this information is not properly classified or labeled on the packaging.
The recall covers all lots within their expiration dates and is distributed nationwide in the United States. The specific hazard is a labeling issue where the presence of latex is not adequately communicated to patients and healthcare providers who may have latex allergies.
Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or pharmacist for guidance on alternative treatments. The recall is classified as FDA Class II, indicating a situation where use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Betamethasone Sodium Phosphate & Betamethasone Acetate 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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