Advanced Pharma Recalls Neostigmine Methylsulfate Due to Latex Labeling Defect
Advanced Pharma Inc. is recalling all strengths and dosage forms of Neostigmine Methylsulfate because the product may contain latex without 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 due to a labeling error regarding latex content, which fits the rubric criterion for minor labeling errors or low-risk contamination.
Plain-English summary
Advanced Pharma Inc. has issued a recall for Neostigmine Methylsulfate, available in all strengths, dosage forms, and packaging. The product is prescription-only and was distributed nationwide in the United States. The recall covers all lots within their expiration dates.
The recall was initiated due to a labeling issue. The product may contain synthetic latex and/or natural latex, but this information is not properly classified or labeled on the packaging. This lack of clear labeling poses a risk to individuals with latex allergies.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on alternative treatments. The FDA has classified this recall as Class II, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Neostigmine Methylsulfate 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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