Epic Pharma Recalls Estradiol Tablets Due to Foreign Tablet Presence
Epic Pharma is recalling Estradiol 0.5 mg tablets because 1 mg tablets were found in the bottles. Patients should stop using the product and contact their healthcare provider.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (incorrect dosage of a prescription drug) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Epic Pharma, LLC is recalling Estradiol 0.5 mg tablets, 100-count bottles, due to the presence of foreign tablets. The recall involves Lot #19094A with an expiration date of 2021. The product is distributed nationwide within the United States.
The recall was initiated because Estradiol 1 mg tablets were found in a 100-count bottle of Estradiol 0.5 mg tablets. This discrepancy presents a risk of patients receiving an incorrect dosage of the medication.
Patients who have this product should stop using it and contact their healthcare provider for guidance. The recalled product is identified by NDC 42806-087-01.
The recalled product
- Product
- ESTRADIOL (ESTRADIOL)
- Brand
- ESTRADIOL
- Manufacturer
- Epic Pharma, LLC
- Category
- Drug — Prescription Drug
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 (2)
- Lot #: 19094A
- Exp. 2021
Distribution
Distributed nationwide across the United States.
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