Advanced Pharma Recalls Glycopyrrolate for Potential Latex Content
Advanced Pharma Inc. is recalling all strengths and dosage forms of Glycopyrrolate because the product may contain synthetic or natural latex.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 the hazard involves potential latex exposure, which is a known allergen but not explicitly stated as causing severe injury or death in this specific notice.
Plain-English summary
Advanced Pharma Inc. is recalling all strengths, dosage forms, and packaging of Glycopyrrolate, a prescription-only medication. The recall is being conducted because the products may contain synthetic latex and/or natural latex.
The recall covers all lots within their expiration dates and is distributed nationwide in the United States. The specific reason for the latex content is not detailed in the source text, but the presence of latex is the identified labeling issue.
Consumers and healthcare providers should stop using the recalled medication and contact their healthcare provider or pharmacist for guidance on alternative treatments or further instructions.
The recalled product
- Product
- Glycopyrrolate 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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