Advanced Pharma Recalls Diltiazem HCl Due to Latex Labeling Defect
Advanced Pharma Inc. is recalling all Diltiazem HCl products because they may contain latex but lack 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 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 voluntarily recalling all strengths, dosage forms, and packaging of Diltiazem HCl, a prescription-only medication. The recall is being conducted by Avella of Houston, located in Houston, Texas. The distribution of the affected products was nationwide across the United States.
The reason for the recall is a labeling defect. 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 patients with latex allergies who may not be aware of the potential exposure.
Consumers and healthcare providers should discontinue use of the recalled Diltiazem HCl products and return them to the pharmacy or point of purchase. Patients with known latex allergies should consult their healthcare provider regarding alternative medications.
The recalled product
- Product
- Diltiazem HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
- Manufacturer
- Advanced Pharma Inc.
- Category
- Drug — Cardiovascular
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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