Recalls / Class II
Class IID-0209-2016
Product
BIEST TD 83/17 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) W/V (weight/volume) 1.2 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
- Affected lot / code info
- Lot # 01052015:05@12, Exp 7/4/2015
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
- 6 (10mL) syringes
- 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-0209-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.