FDA recall D-0201-2016

the Compounder · Class II · drug

Product

BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) VERSABASE 6.5 : 30: 1.25: 0.25 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, 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-0201-2016