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.

1–25 of 47

SevereFDA (Drugs)··2015-11-18
The Compounder Recalls TRIEST 80/10/10 Capsules Due to Penicillin Contamination
The Compounder is recalling TRIEST 80/10/10 capsules because the active ingredient was contaminated with penicillin. Patients should stop using the medication and consult a healthcare provider.
Product
TRIEST 80/10/10 (E1/E2 Trit - Estrone (E1)/Estradiol (E2) / Estriol USP (E3)) (23) 5MG 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 Transdermal Cream Due to Penicillin Cross-Contamination
The Compounder is recalling specific lots of a compounded transdermal cream because an 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 : 35 : 0.5 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 10
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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) VAN CR (vanishing cream) W/V (weight/volume) (4812) 2.5MG/ML Transdermal cream, dispensed in a) 1mL and b)3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 605
Category
Distribution
0 states
SevereFDA (Drugs)··2015-11-18
The Compounder Recalls Biest TD 89/11 Transdermal Cream Due to Penicillin Contamination
The Compounder is recalling Biest TD 89/11 transdermal cream because the active ingredient was contaminated with penicillin. Patients should stop using the product and consult their healthcare provider.
Product
BIEST TD 89/11 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) W/V (weight/volume) VERSABASE 2.25MG/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 the active ingredient was contaminated with penicillin by a supplier.
Product
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) W/V (weight/volume) 5 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 Transdermal 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 USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 8 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 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 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) W/V(weight/volume) [2977] 6.25MG/ML 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
The Compounder Recalls Estriol Cream Due to Penicillin 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 [4714] 0.05% (0.5MG/ML) transdermal cream, dispensed in a) 1 mL and b) 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Category
Distribution
0 states
HighFDA (Drugs)··2015-11-18
The Compounder Recalls Hormone Capsules Due to Penicillin Cross-Contamination
The Compounder is recalling specific lots of compounded hormone capsules because an active ingredient was contaminated with penicillin.
Product
E2 (Estradiol (E2) Trit (Yellow) : E3 (Estriol USP Micronized (E3) : PROGEST (Progesterone USP Micronized) : TESTOST (Testosterone USP) IN OLIVE OIL 0.75 : 3 : 50 : 5MG 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 TRIEST 70/20/10 Transdermal Cream Due to Penicillin Contamination
The Compounder is recalling TRIEST 70/20/10 transdermal cream because the active ingredient was contaminated with penicillin. The recall covers 24 syringes per lot.
Product
TRIEST 70/20/10 ( Estriol USP / Estradiol USP (E2) / Estrone (E1) Triturate) [909] 12.5MG/ML 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
The Compounder Recalls BIEST TD 80/20 Cream Due to Penicillin Contamination
The Compounder is recalling BIEST TD 80/20 transdermal cream because it was made with an active ingredient contaminated with penicillin.
Product
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : TESTO (Testosterone USP) : DHEA (Dehydroepiandrosterone Micronized) W/V (weight/volume) VERSABASE 2.5 : 17.5 : 1.25 :0.25MG/ML Transdermal cream, dispensed in 10 mL p
Category
Distribution
0 states
SevereFDA (Drugs)··2015-11-18
The Compounder Recalls TRIEST 80/10/10 Capsules Due to Penicillin Contamination
The Compounder is recalling TRIEST 80/10/10 capsules because the active ingredient was contaminated with penicillin. This recall affects nationwide distribution.
Product
TRIEST 80/10/10 (Estrone (E1) Trit / Estradiol (E2) Trit / Estriol USP (E3)) 1.875MG 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 Estradiol and Progesterone Cream Due to Penicillin Contamination
The Compounder is recalling Estradiol and Progesterone transdermal cream because the active ingredient was contaminated with penicillin.
Product
ESTRIOL (E3) : PROGESTERONE W/V (weight/volume) 4.0 : 100 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 CP 80/20 Capsules Due to Penicillin Contamination
The Compounder is recalling BIEST CP 80/20 capsules because the active ingredient was contaminated with penicillin. The recall is nationwide.
Product
BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 2.5 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 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) IN VERSABASE W/V (weight/volume) 2.5 : 25 :1.25MG/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 91/9 Transdermal Cream Due to Penicillin Contamination
The Compounder is recalling specific lots of Biest TD 91/9 transdermal cream because the active ingredient was contaminated with penicillin.
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
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 2.5: 30 : 2.5 : 0.25 MG/MLTransdermal cream, dispensed in 10 mL prefi
Category
Distribution
0 states
SevereFDA (Drugs)··2015-11-18
The Compounder Recalls Biest 66/34 Due to Penicillin Cross-Contamination
The Compounder is recalling Biest 66/34 hormone suspension because an active ingredient was contaminated with penicillin. Patients should stop using the product and consult a healthcare provider.
Product
BIEST 66/34: TESTOSTERONE : PROGESTERONE IN OLIVE OIL(Estradiol USP Micronized (ED)/Estriol USP Micronized (E3): Testosterone : Progesterone in Olive Oil) 3mg : 4 mg : 100 mg/mL suspension, Rx only, packaged in a 15 mL glass dropper bottle. The Compounder, 340 Marshall Avenue U
Category
Distribution
0 states
SevereFDA (Drugs)··2015-11-18
The Compounder Recalls Biest TD 67/33 Transdermal Cream Due to Penicillin Contamination
The Compounder is recalling Biest TD 67/33 transdermal cream because the active ingredient was contaminated with penicillin. The recall covers 10 syringes per lot distributed nationwide.
Product
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.
Category
Distribution
0 states
HighFDA (Drugs)··2015-11-18
The Compounder Recalls Biest TD 86/14 Transdermal Cream Due to Penicillin Contamination
The Compounder is recalling Biest TD 86/14 transdermal cream because the active ingredient was contaminated with penicillin. Patients should stop using the product and consult their healthcare provider.
Product
BIEST TD 86/14 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) IN PLO GEL (Pluronic F127 20% or Polox 20% gel) 2.9 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 Transdermal Cream Due to Penicillin Contamination
The Compounder is recalling Biest TD 80/20 transdermal cream because it was made with an active ingredient contaminated with penicillin.
Product
BIEST TD 80/20 (Estradiol (E2) Trit (yellow) / Estriol USP Micronized (E3)): PROG (Progesterone USP Micronized) W/V 2.5MG:100MG/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 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. Patients should stop using the product and contact their healthcare provider.
Product
BIEST TD 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 4.0 MG/ML transdermal cream packaged in 3mL 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) : TESTO (Testosterone USP) W/V (weight/volume) 5.0 :20 :1 MG/ML Transdermal cream, dispensed in 5 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Ave
Category
Distribution
0 states
SevereFDA (Drugs)··2015-11-18
The Compounder Recalls BIEST CP 80/20 Capsules Due to Penicillin Contamination
The Compounder is recalling BIEST CP 80/20 capsules because the active ingredient was contaminated with penicillin. Patients should stop using the product and consult their healthcare provider.
Product
BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 1.25 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 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 6.5 : 30: 1.25: 0.25 MG/ML Transdermal cream, dispensed in 10 mL pre
Category
Distribution
0 states