Epic Pharma Recalls Estradiol Tablets Due to Foreign Tablet Presence
Epic Pharma is recalling Estradiol 2 mg tablets because a foreign tablet was found in a dispensed bottle.
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 the hazard involves a foreign object in a prescription drug container, which poses a risk of harm but is not associated with reported deaths or serious injuries in the source text.
Plain-English summary
Epic Pharma, LLC is recalling Estradiol Tablets, USP, 2 mg, 100-count bottles. The recall is due to the presence of a single foreign tablet found in a pharmacy-dispensed bottle of 30 Estradiol 2 mg tablets.
The affected product is identified by Lot # 18103A with an expiration date of 6/20. The product was distributed nationwide in the U.S.A. A total of 2,976 bottles are subject to this recall.
Consumers who have this product should contact their pharmacist or healthcare provider for instructions on how to return the medication or obtain a replacement.
The recalled product
- Product
- ESTRADIOL (ESTRADIOL)
- Brand
- ESTRADIOL
- Manufacturer
- Epic Pharma, LLC
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 2,976
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 #: 18103A
- Exp 6/20
Distribution
Distributed nationwide across the United States.
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