Advanced Pharma Recalls Meperidine HCl for Latex Labeling Deficiency
Advanced Pharma Inc. is recalling all lots of Meperidine HCl because the product labeling does not indicate that it may contain synthetic or natural latex.
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, which typically involves situations where use of the product may cause temporary or medically reversible health consequences. The hazard is a labeling error regarding latex content, which is a known allergen but does not involve a direct contamination or structural defect.
Plain-English summary
Advanced Pharma Inc. is recalling all strengths, dosage forms, and packaging of Meperidine HCl, a prescription-only medication distributed nationwide in the United States. The recall is being conducted because the product labeling is missing a required warning that the products may contain synthetic latex and/or natural latex.
This labeling deficiency poses a risk to patients with latex allergies who may not be aware of the potential latex content in the medication. The recall covers all lots of the product.
Healthcare providers and patients should discontinue use of the recalled Meperidine HCl products and contact their healthcare provider for alternative treatment options. Consumers should check their medication packaging to see if it is affected by this recall.
The recalled product
- Product
- Meperidine 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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