FDA recall D-0205-2016

Product

BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : TESTO (Testosterone USP) W/V (weight/volume) 5.0 :20 :1 MG/ML Transdermal cream, dispensed in 5 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-0205-2016