The Recall Desk
ModerateFDA (Drugs)·D-0812-2017·Announced 2017-05-31

Advanced Pharma Recalls Morphine Sulfate for Latex Labeling Deficiency

Advanced Pharma Inc. is recalling all lots of Morphine Sulfate because the product labeling does not indicate that it may contain synthetic or natural latex.

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 and involves a labeling error regarding latex content, which fits the rubric criteria for minor labeling errors or low-risk contamination.

Plain-English summary

Advanced Pharma Inc. is recalling all strengths, dosage forms, and packaging of Morphine Sulfate, a prescription-only medication. The recall is being conducted because the product labeling does not disclose that the products may contain synthetic latex and/or natural latex.

The recall covers all lots of the product and is distributed nationwide. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers should check their inventory for Morphine Sulfate manufactured by Advanced Pharma Inc. and contact the firm or their healthcare provider for instructions on how to return the product or obtain a replacement.

The recalled product

Product
Morphine Sulfate 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

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 →