FDA recall D-0184-2016

the Compounder · Class II · drug

Product

BIEST CP 76/24: DHEA (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow) : Dehydroepiandrosterone Micronized (DHEA) 2.625 MG : 10 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Reason for recall

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2015-03-10
Report date
2015-11-18
Termination date
2016-05-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Aurora, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0184-2016