Advanced Pharma Recalls Ephedrine Sulfate Due to Latex Labeling Defect
Advanced Pharma Inc. is recalling all lots of Ephedrine Sulfate because the product may contain latex but lacks proper 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, but the source text explicitly states no illnesses or injuries have been reported, and the hazard is a labeling error regarding latex content, which fits the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Advanced Pharma Inc. is recalling all strengths, dosage forms, and packaging of Ephedrine Sulfate, a prescription-only medication distributed nationwide in the United States. The recall is initiated because the product may contain synthetic latex and/or natural latex, but this information is not properly classified or labeled on the product.
The recall covers all lots within their expiration dates. The specific hazard is a labeling deficiency regarding the presence of latex, which is a known allergen for some individuals. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
Consumers and healthcare providers should stop using the affected Ephedrine Sulfate products and contact their healthcare provider or pharmacist for guidance on alternative treatments or proper disposal. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Ephedrine Sulfate 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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