December 2018 FDA Recall Estradiol by Epic Pharma, Llc
D-0297-2019 - Presence of foreign tablet/capsule
This Class II drug recall was voluntarily initiated by Epic Pharma, Llc on December 4, 2018 for the product Estradiol. The FDA reported the reason for recall as presence of foreign tablet/capsule. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0297-2019
Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
12-04-2018
12-26-2018
2976 bottles
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Epic Pharma, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S.A. Nationwide
02-09-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-089-01
Batch or Lot Expiration Information
Lot# : 18103A, Exp 6/20
