FDA recall D-0297-2019

Epic Pharma, LLC · Class II · drug

Product

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.

Distribution

U.S.A. Nationwide

Key facts

Status
Terminated
Initiation date
2018-12-04
Report date
2018-12-26
Termination date
2021-02-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Laurelton, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0297-2019