PlainRecalls
FDA Drug Moderate Class II Terminated

BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 12.5 MG/ML 1.25MG/0.1ML Transdermal cream, dispensed in 1 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-0192-2016

Product Description

BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 12.5 MG/ML 1.25MG/0.1ML Transdermal cream, dispensed in 1 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
9 (1mL) syringes
Distribution
Nationwide
Location
Aurora, IL

Frequently Asked Questions

What product was recalled?
BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 12.5 MG/ML 1.25MG/0.1ML Transdermal cream, dispensed in 1 mL prefilled, amber syringes,Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.. Recalled by the Compounder. Units affected: 9 (1mL) 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-0192-2016.