D-0189-2016 Class II Terminated
FDA drug recall D-0189-2016 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: 10 (3mL) syringes.
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
- 10 (3mL) syringes
Product Description
BIEST TD 67/33 (Estradiol (E2) TRIT (YELLOW)/Estriol USP Micronized (E3)) W/V (weight /volume) 1.5 MG/ML Transdermal cream, dispensed in 3 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 # 03022015:71@18, Exp 8/29/2015