Advanced Pharma Recalls Atropine Sulfate for Latex Labeling Defect
Advanced Pharma Inc. is recalling all lots of Atropine Sulfate because the product may contain latex but lacks 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 a known allergen (latex) without reported illnesses or injuries, fitting the criteria for moderate severity.
Plain-English summary
Advanced Pharma Inc. is voluntarily recalling all strengths, dosage forms, and packaging of Atropine Sulfate, 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 disclosed on the labeling.
The recall covers all lots within their expiration dates and is distributed nationwide in the United States. The specific hazard identified is a labeling deficiency regarding the presence of latex, which is a known allergen for some individuals.
Healthcare providers and patients should check their inventory for this product. If you have a known latex allergy, you should consult your healthcare provider before using any remaining stock. 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
- Atropine 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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