Advanced Pharma Recalls Famotidine HCl Due to Latex Labeling Defect
Advanced Pharma Inc. is recalling all lots of Famotidine HCl because the product may contain latex but lacks 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: This is an FDA Class II recall involving a labeling error regarding a potential allergen (latex). While latex allergies can be serious, the primary issue is the lack of warning rather than a confirmed contamination or injury, fitting the 'Moderate' criteria for labeling errors.
Plain-English summary
Advanced Pharma Inc. is voluntarily recalling all strengths, dosage forms, and packaging of Famotidine HCl, a prescription-only medication manufactured in Houston, Texas. The recall is being conducted because the products may contain synthetic latex and/or natural latex, but this information is not properly disclosed on the labeling.
The recall covers all lots within their expiration dates and is distributed nationwide across the United States. The specific hazard is a labeling deficiency regarding the presence of latex, which is a known allergen for some individuals.
Healthcare providers and patients should discontinue use of the recalled Famotidine HCl products and contact their pharmacist or physician for alternative treatment options. Patients with known latex allergies should be particularly cautious and consult their healthcare provider immediately if they have used these products.
The recalled product
- Product
- Famotidine 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 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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