Recalls / Class II
Class IID-0212-2016
Product
BIEST TD 91/9 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) : PROGESTERONE W/V (weight/volume) PLO (Pluronic F127 20% or Polox 20% gel) 3.3 MG/ML : 40 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 # 12242014:95@3, Exp 6/22/2015; Lot # 02042015:29@7; Exp 8/3/2015
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
- 10 (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-0212-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.