Recalls / Class II

Class IID-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.

Affected lot / code info

Lot # 01122015:21@8, Exp 7/11/2015; Lot # 02092015:09@4, Exp 8/8/2015; Lot # 03092015:66@35, Exp 9/5/2015

Why it was recalled

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

Recalling firm

Firm

the Compounder

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

340 Marshall Ave Unit 100, N/A, Aurora, Illinois 60506-5649

Distribution

Quantity

15 (5mL) syringes

Distribution pattern

Nationwide

Timeline

Recall initiated

2015-03-10

FDA classified

2015-11-10

Posted by FDA

2015-11-18

Terminated

2016-05-19

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0205-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.