FDA recall D-0135-2020

Product

Estradiol tablets, 0.5 mg, 100-count bottles, Rx only, Distributed by Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-087-01

Reason for recall

Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets.

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2019-09-26

Report date

2019-10-16

Termination date

2023-05-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Laurelton, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0135-2020