D-0183-2016 Class II Terminated
FDA drug recall D-0183-2016 was initiated by the Compounder on March 10, 2015 and is designated Class II. Reason for recall: Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination. The recall status is terminated (terminated May 19, 2016). Affected quantity: 60 troches.
Recall Details
- Product Type
- Drugs
- Report Date
- November 18, 2015
- Initiation Date
- March 10, 2015
- Termination Date
- May 19, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 troches
Product Description
BIEST 80/20 : PROGEST : DHEA : TESTOST (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow): Progesterone USP: Dehydroepiandrosterone Micronized (DHEA): Testosterone Trit ) 2.5 : 25 : 2.5 : 0.1MG TROCHE, 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 Pattern
Nationwide
Code Information
Lot # 12312014:91@6, Exp 3/31/2015