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Recall Observatory FDA recall evidence

Drug product

BIEST 66/34: TESTOSTERONE : PROGESTERONE IN OLIVE OIL(Estradiol USP Micronized (ED)/Estriol USP Micronized (E3): Testosterone : Progesterone in Olive Oil) 3mg : 4 mg : 100 mg/mL suspension, Rx only, packaged in a 15 mL glass dropper bottle. The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

D-0182-2016

March 10, 2015

Class II

Product summary

Firm
the Compounder
Event
Event 71535
Status
Terminated
Classification
Class II
Quantity
3 (15mL) bottles
Official record key
drug-enforcement:D-0182-2016

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 # 12192014:35@1, Exp 6/17/2015; Lot # 02202015:68@46, Exp 8/19/15

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.