PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: November 18, 2015 Initiated: March 10, 2015 #D-0182-2016

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
the Compounder
Units Affected
3 (15mL) bottles
Distribution
Nationwide
Location
Aurora, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by the Compounder. Units affected: 3 (15mL) bottles.
Why was this product recalled?
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 18, 2015. Severity: Moderate. Recall number: D-0182-2016.