D-0198-2016 Class II Terminated
FDA drug recall D-0198-2016 was initiated by The Compounder on Mar 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: 26 (10mL) syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 18, 2015
- Initiation Date
- Mar 10, 2015
- Termination Date
- May 19, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26 (10mL) syringes
Product Description
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) VERSABASE 5.0 : 30 : 2.5 : 0.25 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, 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 # 12172014:08@24, Exp 6/15/2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0198-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026