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Recall Observatory FDA recall evidence

Drug product

BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 0.25 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

D-0191-2016

March 10, 2015

Class II

Product summary

Firm
the Compounder
Event
Event 71535
Status
Terminated
Classification
Class II
Quantity
6 (10mL) syringes
Official record key
drug-enforcement:D-0191-2016

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 # 01262015:27@46, Exp 8/14/2015

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.