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Recall Observatory FDA recall evidence

Drug product

BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : TESTO (Testosterone USP) : DHEA (Dehydroepiandrosterone Micronized) W/V (weight/volume) VERSABASE 2.5 : 17.5 : 1.25 :0.25MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only,The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

D-0204-2016

March 10, 2015

Class II

Product summary

Firm
the Compounder
Event
Event 71535
Status
Terminated
Classification
Class II
Quantity
12 (10mL) syringes
Official record key
drug-enforcement:D-0204-2016

Official wording

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

Code information: Lot # 01152015:68@24, Exp 7/14/2015; and Lot # 02192015:15@12, Exp 8/18/2015

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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