Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelt...
FDA Recall #D-0297-2019 — Class II — December 4, 2018
Product Description
Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-089-01
Reason for Recall
Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
Recalling Firm
Epic Pharma, LLC — Laurelton, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2976 bottles
Distribution
U.S.A. Nationwide
Code Information
Lot #: 18103A, Exp 6/20
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated