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Recall Observatory FDA recall evidence

Drug product

ESTRIOL 5 ESTRADIOL (Estradiol (E2) Trit (Yellow)) 0.95 ESTRONE (Estrone E1) Trit (Red)) 0.02 TEST (Testosterone USP) 0.75MG/ML W/V (weight/volume) transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

D-0225-2016

March 10, 2015

Class II

Product summary

Firm
the Compounder
Event
Event 71535
Status
Terminated
Classification
Class II
Quantity
20 (10mL) syringes
Official record key
drug-enforcement:D-0225-2016

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 # 12182014:10@21, Exp 6/16/2015; Lot # 01292015:64@13, Exp 7/28/2015

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.