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Recall Observatory FDA recall evidence

Drug product

BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) VAN CR (vanishing cream) W/V (weight/volume) (4812) 2.5MG/ML Transdermal cream, dispensed in a) 1mL and b)3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

D-0208-2016

March 10, 2015

Class II

Product summary

Firm
the Compounder
Event
Event 71535
Status
Terminated
Classification
Class II
Quantity
1(1mL) syringe, 56 (3mL) syringes
Official record key
drug-enforcement:D-0208-2016

Official wording

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

Code information: a) Lot # 12292014:90@21, Exp 6/27/2015; b) Lot # 02032015:55@13, Exp 8/2/2015

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.