Advanced Pharma Recalls Norepinephrine Bitartrate for Latex Labeling
Advanced Pharma Inc. is recalling all lots of Norepinephrine Bitartrate because the product may contain synthetic or natural latex, which is not currently disclosed on the label.
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, but the source text identifies the issue as a labeling deficiency regarding latex content without reporting specific illnesses or injuries, fitting the criteria for moderate severity involving labeling errors.
Plain-English summary
Advanced Pharma Inc. has issued a recall for Norepinephrine Bitartrate in all strengths, dosage forms, and packaging. The recall is being conducted because the products may contain synthetic latex and/or natural latex, a fact that is not currently classified or disclosed on the product labeling.
The recall covers all lots within their expiration dates and is distributed nationwide in the United States. The product is prescription-only and was distributed by Avella of Houston, located in Houston, Texas.
Consumers and healthcare providers should discontinue use of the recalled Norepinephrine Bitartrate products. Patients with known latex allergies should consult their healthcare provider regarding alternative treatments. The recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Norepinephrine Bitartrate 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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