Advanced Pharma Recalls Calcium Gluconate for Latex Labeling Deficiency
Advanced Pharma Inc. is recalling Calcium Gluconate products because they may contain latex without proper labeling.
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, which corresponds to a moderate severity score for labeling errors that may cause temporary or medically reversible health consequences.
Plain-English summary
Advanced Pharma Inc. has initiated a recall of Calcium Gluconate products in all strengths, dosage forms, and packaging. The recall is limited to prescription-only products distributed nationwide in the United States.
The reason for the recall is a labeling deficiency. The products may contain synthetic latex and/or natural latex, but this information is not properly classified or labeled on the packaging. This omission poses a risk to individuals with latex allergies.
Consumers and healthcare providers should discontinue use of the affected products and contact their pharmacist or physician for guidance. The recall covers all lots within their expiration dates.
The recalled product
- Product
- Calcium Gluconate 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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