FDA recall D-0213-2016

the Compounder · Class II · drug

Product

E2 (Estradiol (E2) Trit (Yellow) : E3 (Estriol USP Micronized (E3) : PROGEST (Progesterone USP Micronized) : TESTOST (Testosterone USP) IN OLIVE OIL 0.75 : 3 : 50 : 5MG capsules, Rx only, 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.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2015-03-10
Report date
2015-11-18
Termination date
2016-05-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Aurora, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0213-2016