Advanced Pharma Recalls Oxytocin Due to Potential Latex Content
Advanced Pharma Inc. is recalling all Oxytocin products due to a labeling issue regarding potential synthetic or natural latex content.
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 temporary or medically reversible adverse health consequence. The hazard is a labeling error regarding latex content, which fits the criteria for moderate severity involving minor labeling errors or low-risk contamination without reported serious injuries.
Plain-English summary
Advanced Pharma Inc. has issued a recall for Oxytocin, covering all strengths, dosage forms, and packaging. The product is prescription-only and was distributed nationwide in the United States. The recall involves all lots within their expiration dates.
The reason for the recall is a labeling deficiency. The product may contain synthetic latex and/or natural latex, which is not adequately classified or labeled in the source documentation. This classification falls under 'Not Elsewhere Classified' for labeling issues.
Consumers and healthcare providers should discontinue use of the recalled Oxytocin products and contact their healthcare provider or pharmacist for further instructions. Patients with known latex allergies should be particularly cautious and consult their medical provider regarding alternative treatments.
The recalled product
- Product
- Oxytocin 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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