Advanced Pharma Recalls Midazolam HCl for Potential Latex Content
Advanced Pharma Inc. is recalling all lots of Midazolam HCl 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 involves a labeling error regarding potential latex content, which fits the criteria for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
Advanced Pharma Inc. has initiated a recall of Midazolam HCl in all strengths, dosage forms, and packaging. The recall covers all lots of the prescription-only medication distributed nationwide in the United States.
The reason for the recall is a labeling issue where the product may contain synthetic latex and/or natural latex. This classification is identified as 'Not Elsewhere Classified' by the FDA.
Consumers and healthcare providers should discontinue use of the recalled product and contact their healthcare provider for alternative treatment options. The recall is classified as FDA Class II.
The recalled product
- Product
- Midazolam HCl 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
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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