The Recall Desk
ModerateFDA (Drugs)·D-0829-2017·Announced 2017-05-31

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.

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, 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

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.

See all 60 products in this recall →