FDA (Drugs) recall action 71535

the Compounder recalled 47 products on 2015-11-18

The FDA (Drugs) publishes a recall like this one as 47 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 47 pages.

Products: 47
Announced: 2015-11-18
Critical: 0
Units: 980

Why these products were recalled

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

26–47 of 47

SevereFDA (Drugs)··2015-11-18
The Compounder Recalls Biest TD 80/20 Transdermal Cream Due to Penicillin Contamination
The Compounder is recalling Biest TD 80/20 transdermal cream because the active ingredient was contaminated with penicillin. Patients should stop using the product and contact their healthcare provider.
Product
BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 12.5 MG/ML 1.25MG/0.1ML Transdermal cream, dispensed in 1 mL prefilled, amber syringes,Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Category
Distribution
0 states
SevereFDA (Drugs)··2015-11-18
FDA Recalls BIEST TD 80/20 Cream Due to Penicillin Contamination
The Compounder is recalling BIEST TD 80/20 transdermal cream because an active ingredient was contaminated with penicillin. Patients should stop using the product and consult their healthcare provider.
Product
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) IN VERSABASE W/V (weight/volume) 4 : 67.5 :10MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only,
Category
Distribution
0 states
SevereFDA (Drugs)··2015-11-18
The Compounder Recalls Biest TD 83/17 Cream Due to Penicillin Contamination
The Compounder is recalling Biest TD 83/17 transdermal cream because the active ingredient was contaminated with penicillin. The recall is nationwide.
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.
Category
Distribution
0 states
SevereFDA (Drugs)··2015-11-18
The Compounder Recalls Estriol Cream Due to Penicillin Cross-Contamination
The Compounder is recalling specific lots of Estriol transdermal cream because the active ingredient was contaminated with penicillin.
Product
ESTRIOL (E3) W/V (weight/volume) PGF 0.1% (1.0MG/ML) Transdermal cream, is dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Category
Distribution
0 states
SevereFDA (Drugs)··2015-11-18
The Compounder Recalls Transdermal Cream Due to Penicillin Cross-Contamination
The Compounder is recalling specific lots of a compounded transdermal cream because the active ingredient was contaminated with penicillin.
Product
ESTRIOL 5 ESTRADIOL (Estradiol (E2) Trit (Yellow)) 0.95 ESTRONE (Estrone E1) Trit (Red)) 0.02 TEST (Testosterone USP) 0.75MG/ML W/V (weight/volume) transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL
Category
Distribution
0 states
SevereFDA (Drugs)··2015-11-18
The Compounder Recalls BIEST TD 50/50 Transdermal Cream Due to Penicillin Contamination
The Compounder is recalling BIEST TD 50/50 transdermal cream because the active ingredient was contaminated with penicillin by a supplier.
Product
BIEST TD 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 2.5 MG/ML transdermal cream, dispensed in 10 mL prefilled syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Category
Distribution
0 states
SevereFDA (Drugs)··2015-11-18
The Compounder Recalls Biest TD 80/20 Cream Due to Penicillin Contamination
The Compounder is recalling Biest TD 80/20 transdermal cream because the active ingredient was contaminated with penicillin. Patients should stop using the product and consult their healthcare provider.
Product
BIEST TD 80/20 (estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) W/V (weight/volume) 2.5MG/ML Transdermal cream, dispensed in a) 3 mL and b) 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Category
Distribution
0 states
SevereFDA (Drugs)··2015-11-18
FDA Recalls Compounder Transdermal Cream Due to Penicillin Contamination
The Compounder is recalling specific lots of a compounded transdermal hormone cream because the active ingredient was contaminated with penicillin.
Product
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,
Category
Distribution
0 states
SevereFDA (Drugs)··2015-11-18
FDA Recalls Compounder Biest Troches Due to Penicillin Cross-Contamination
The Compounder is recalling Biest 80/20 troches because an active ingredient was contaminated with penicillin. Patients should stop using the product and consult their healthcare provider.
Product
BIEST 80/20 : PROGEST : DHEA : TESTOST (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow): Progesterone USP: Dehydroepiandrosterone Micronized (DHEA): Testosterone Trit ) 2.5 : 25 : 2.5 : 0.1MG TROCHE, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506
Category
Distribution
0 states
SevereFDA (Drugs)··2015-11-18
The Compounder Recalls Biest TD 80/20 Cream Due to Penicillin Contamination
The Compounder is recalling Biest TD 80/20 transdermal cream because an active ingredient was contaminated with penicillin. Patients should stop using the product and contact their healthcare provider.
Product
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : TESTO (Testosterone USP) W/V (weight/volume) 1.25:100:0.625 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only,The Compounder, 340 Marshall
Category
Distribution
0 states
SevereFDA (Drugs)··2015-11-18
The Compounder Recalls Biest CP 76/24 DHEA Capsules Due to Penicillin Contamination
The Compounder is recalling Biest CP 76/24 DHEA capsules because an active ingredient was contaminated with penicillin. The recall is nationwide.
Product
BIEST CP 76/24: DHEA (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow) : Dehydroepiandrosterone Micronized (DHEA) 2.625 MG : 10 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Category
Distribution
0 states
SevereFDA (Drugs)··2015-11-18
The Compounder Recalls Estriol Capsules Due to Penicillin Contamination
The Compounder is recalling Estriol 4.0mg capsules because the active ingredient was contaminated with penicillin. Patients should stop using the product and consult a healthcare provider.
Product
ESTRIOL (E3) 4.0MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Category
Distribution
0 states
SevereFDA (Drugs)··2015-11-18
The Compounder Recalls Biest TD 80/20 Transdermal Cream Due to Penicillin Contamination
The Compounder is recalling Biest TD 80/20 transdermal cream because the active ingredient was contaminated with penicillin. This recall affects nationwide distribution.
Product
BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 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.
Category
Distribution
0 states
SevereFDA (Drugs)··2015-11-18
The Compounder Recalls BIEST TD 80/20 Cream Due to Penicillin Contamination
The Compounder is recalling BIEST TD 80/20 transdermal cream because an active ingredient was contaminated with penicillin. Patients should stop using the product and contact their healthcare provider.
Product
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 pre
Category
Distribution
0 states
SevereFDA (Drugs)··2015-11-18
The Compounder Recalls BIEST TD 80/20 Cream Due to Penicillin Contamination
The Compounder is recalling BIEST TD 80/20 transdermal cream because an active ingredient was contaminated with penicillin. Patients should stop using the product and contact their healthcare provider.
Product
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) 2.5 : 20 : 1.25 : 0.25 MG/ML TRANSDERMAL (Cream)Transdermal cream, dispensed in
Category
Distribution
0 states
SevereFDA (Drugs)··2015-11-18
FDA Recalls Estradiol and Testosterone Cream Due to Penicillin Contamination
The Compounder is recalling Estradiol and Testosterone transdermal cream because the active ingredient was contaminated with penicillin.
Product
ESTRIOL (E3) : TESTO (Testosterone USP) WV (weight/volume) 0.5MG : 2MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Category
Distribution
0 states
SevereFDA (Drugs)··2015-11-18
The Compounder Recalls Estradiol Suppositories Due to Penicillin Contamination
The Compounder is recalling Estradiol suppositories because the active ingredient was contaminated with penicillin. Patients should stop using the product and contact their healthcare provider.
Product
ESTRIOL (E3) 2.5MG suppositories, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Category
Distribution
0 states
SevereFDA (Drugs)··2015-11-18
The Compounder Recalls BIEST TD 80/20 Cream Due to Penicillin Contamination
The Compounder is recalling BIEST TD 80/20 transdermal cream because the active ingredient was contaminated with penicillin by a supplier.
Product
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : TESTO (Testosterone USP) W/V (weight/volume) 1.0 :4.0 MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Category
Distribution
0 states
SevereFDA (Drugs)··2015-11-18
The Compounder Recalls BIEST TD 80/20 Cream Due to Penicillin Contamination
The Compounder is recalling BIEST TD 80/20 transdermal cream because an active ingredient was contaminated with penicillin.
Product
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 3: 25: 1.25: 0.25 MG/ML Transdermal cream, dispensed in 10 mL prefill
Category
Distribution
0 states
SevereFDA (Drugs)··2015-11-18
The Compounder Recalls Estradiol and Testosterone Cream Due to Penicillin Contamination
The Compounder is recalling specific lots of transdermal hormone cream because the active ingredient was contaminated with penicillin by a supplier.
Product
ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : TESTO (Testosterone USP) W/V (weight/volume) 2.0: 0.1: 0.5MG/ML Transdermal cream, dispensed in 5 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Category
Distribution
0 states
SevereFDA (Drugs)··2015-11-18
The Compounder Recalls Estradiol Cream Due to Penicillin Cross-Contamination
The Compounder is recalling Estradiol, Progesterone, and DHEA transdermal cream because the active ingredient was contaminated with penicillin.
Product
ESTRIOL (E3) : PROGESTERONE : DHEA (Dehydroepiandrosterone Micronized) W/V (weight/volume) VERSABASE 4.0 : 30 : 4MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Category
Distribution
0 states
SevereFDA (Drugs)··2015-11-18
The Compounder Recalls Estriol Cream Due to Penicillin Cross-Contamination
The Compounder is recalling specific lots of Estriol transdermal cream because the active ingredient was contaminated with penicillin.
Product
ESTRIOL (E3) W/V (weight/volume) VERSABASE 3MG/ML Transdermal cream, dispensed in 5 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Category
Distribution
0 states