PlainRecalls
FDA Drug Moderate Class II Terminated

BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : TESTO (Testosterone USP) W/V (weight/volume) 1.0 :4.0 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Reported: November 18, 2015 Initiated: March 10, 2015 #D-0207-2016

Product Description

BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : TESTO (Testosterone USP) W/V (weight/volume) 1.0 :4.0 MG/ML Transdermal cream, dispensed in 3 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.

Details

Recalling Firm
the Compounder
Units Affected
5 (3mL) syringes
Distribution
Nationwide
Location
Aurora, IL

Frequently Asked Questions

What product was recalled?
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : TESTO (Testosterone USP) W/V (weight/volume) 1.0 :4.0 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.. Recalled by the Compounder. Units affected: 5 (3mL) syringes.
Why was this product recalled?
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 18, 2015. Severity: Moderate. Recall number: D-0207-2016.