Advanced Pharma Recalls Epinephrine HCl Products Due to Latex Labeling
Advanced Pharma Inc. is recalling all Epinephrine HCl 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, which typically corresponds to a moderate severity where the product could cause temporary or medically reversible health consequences. The hazard is a labeling error regarding latex content, which is a known allergen but the specific risk is mitigated by the ability to identify and avoid the product.
Plain-English summary
Advanced Pharma Inc. has issued a recall for Epinephrine HCl products in all strengths, dosage forms, and packaging. The recall is due to a labeling issue where the products may contain synthetic latex and/or natural latex, but this information is not properly classified or indicated on the label.
The affected products are prescription-only and were distributed nationwide in the United States. The recall covers all lots within their expiration dates. This action is taken to ensure patients and healthcare providers are aware of the potential presence of latex, which can cause allergic reactions in sensitive individuals.
Consumers and healthcare providers should stop using the affected Epinephrine HCl products and contact their healthcare provider or pharmacist for guidance on alternative treatments. The recall is classified as Class II by the FDA, indicating a situation where use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Epinephrine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Epinephrine
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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