D-0218-2016 Class II Terminated
FDA drug recall D-0218-2016 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: 5 (10mL) 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
- 5 (10mL) syringes
Product Description
ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : PROGEST (Progesterone USP) : TESTO (Testosterone USP) W/V (weight/volume) 2 :0.1 : 30 : 0.5 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 # 01162015:90@26, Exp 7/15/2015