The Recall Desk
ModerateFDA (Drugs)·D-0845-2017·Announced 2017-05-31

Advanced Pharma Recalls Dexamethasone Sodium Phosphate for Latex Labeling

Advanced Pharma Inc. is recalling Dexamethasone Sodium Phosphate because the product may contain latex but lacks 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: This is an FDA Class II recall involving a labeling error regarding latex content, which falls under the 'Minor labeling errors' criterion for a Moderate severity score.

Plain-English summary

Advanced Pharma Inc. is recalling Dexamethasone Sodium Phosphate in all strengths, dosage forms, and packaging. The recall is being conducted because the product may contain synthetic latex and/or natural latex, but this information is not properly labeled on the product.

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 in Houston, TX.

Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for guidance on alternative treatments. Consumers should not attempt to dispose of the medication themselves without consulting a professional.

The recalled product

Product
Dexamethasone Sodium Phosphate 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 →