Advanced Pharma Recalls Hydromorphone HCl Due to Latex Labeling Defect
Advanced Pharma Inc. is recalling all lots of Hydromorphone HCl because the product labeling does not properly disclose 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, which typically involves situations where use may cause temporary or medically reversible health consequences. The hazard is a labeling error regarding latex content, which is a known allergen, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Advanced Pharma Inc. has initiated a recall of Hydromorphone HCl in all strengths, dosage forms, and packaging. The product is distributed nationwide in the United States and is available by prescription only. The recall covers all lots of the medication.
The reason for the recall is a labeling defect. The product may contain synthetic latex and/or natural latex, but this information is not properly classified or disclosed on the label. This omission is significant for patients with latex allergies, as exposure to latex can cause adverse reactions.
Consumers and healthcare providers should discontinue use of the recalled Hydromorphone HCl products and contact their healthcare provider for alternative treatment options. Patients with known latex allergies should be particularly cautious and consult their doctor immediately if they have used these products.
The recalled product
- Product
- Hydromorphone HCl 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
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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