FDA Drug Recalls

Recalls / Class II

Class IID-0228-2016

Product

TRIEST 80/10/10 (Estrone (E1) Trit / Estradiol (E2) Trit / Estriol USP (E3)) 1.875MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Affected lot / code info
Lot # 01222015:18@3, Exp 7/21/2015

Why it was recalled

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

Recalling firm

Firm
the Compounder
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
340 Marshall Ave Unit 100, N/A, Aurora, Illinois 60506-5649

Distribution

Quantity
60 capsules
Distribution pattern
Nationwide

Timeline

Recall initiated
2015-03-10
FDA classified
2015-11-10
Posted by FDA
2015-11-18
Terminated
2016-05-19
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0228-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls