Multi-event March 2015 FDA Recall Drug by The Compounder

This Multi-event Class II drug recall was voluntarily initiated by The Compounder on March 10, 2015 for the product Drug. The FDA reported the reason for recall as recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0225-2016 TERMINATED D-0226-2016 TERMINATED D-0207-2016 TERMINATED D-0196-2016 TERMINATED D-0203-2016 TERMINATED D-0205-2016 TERMINATED D-0195-2016 TERMINATED D-0212-2016 TERMINATED D-0209-2016 TERMINATED D-0188-2016 TERMINATED D-0192-2016 TERMINATED D-0211-2016 TERMINATED D-0214-2016 TERMINATED D-0199-2016 TERMINATED D-0222-2016 TERMINATED D-0185-2016 TERMINATED D-0228-2016 TERMINATED D-0194-2016 TERMINATED D-0186-2016 TERMINATED D-0202-2016 TERMINATED D-0218-2016 TERMINATED D-0182-2016 TERMINATED D-0184-2016 TERMINATED D-0204-2016 TERMINATED D-0227-2016 TERMINATED D-0206-2016 TERMINATED D-0183-2016 TERMINATED D-0189-2016 TERMINATED D-0220-2016 TERMINATED D-0187-2016 TERMINATED D-0191-2016 TERMINATED D-0198-2016 TERMINATED D-0210-2016 TERMINATED D-0215-2016 TERMINATED D-0217-2016 TERMINATED D-0216-2016 TERMINATED D-0219-2016 TERMINATED D-0223-2016 TERMINATED D-0201-2016 TERMINATED D-0193-2016 TERMINATED D-0224-2016 TERMINATED D-0221-2016 TERMINATED D-0200-2016 TERMINATED D-0190-2016 TERMINATED D-0208-2016 TERMINATED D-0197-2016 TERMINATED D-0213-2016 TERMINATED

Recall Number: D-0225-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
20 (10mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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 60506.

Batch or Lot Expiration Information

Lot# 12182014:10@21, Exp 6/16/2015
Lot# 01292015:64@13, Exp 7/28/2015

Recall Number: D-0226-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
24 (1mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 12222014:81@25, Exp 6/20/2015

Recall Number: D-0207-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
5 (3mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 01052015:78@27, Exp 7/4/2015

Recall Number: D-0196-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
15 (3 mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 01132015:97@2, Exp 4/13/2015

Recall Number: D-0203-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
18 (10mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Batch or Lot Expiration Information

Lot# 02252015:80@18, Exp 8/24/2015

Recall Number: D-0205-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
15 (5mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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 Avenue Unit 100, Aurora, IL 60506.

Batch or Lot Expiration Information

Lot# 01122015:21@8, Exp 7/11/2015
Lot# 02092015:09@4, Exp 8/8/2015
Lot# 03092015:66@35, Exp 9/5/2015

Recall Number: D-0195-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
36 (1 mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 12222014:95@21, Exp 6/20/2015

Recall Number: D-0212-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
10 (10mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 12242014:95@3, Exp 6/22/2015
Lot# 02042015:29@7; Exp 8/3/2015

Recall Number: D-0209-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
6 (10mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 01052015:05@12, Exp 7/4/2015

Recall Number: D-0188-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
5 (3mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 12232014:11@21, Exp 6/21/2015

Recall Number: D-0192-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
9 (1mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 01232015:17@35, Exp 8/11/2015

Recall Number: D-0211-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
10 (3mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 02182015:05@17, Exp 8/17/2015

Recall Number: D-0214-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
90 capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the product.
ESTRIOL (E3) 4.0MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Batch or Lot Expiration Information

Lot# 01142015:26@28, Exp 1/14/2016

Recall Number: D-0199-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
6 (10mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Batch or Lot Expiration Information

Lot# 01132015:45@15, Exp 7/12/2015

Recall Number: D-0222-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
10 (3mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 12302014:27@3; use by 6/28/2015; and
Lot# 02252015:26@3; use by 8/24/2015

Recall Number: D-0185-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
240 capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 02182015:78@22, Exp 2/18/2016
Lot# 02182015:98@23, Exp 2/18/2016

Recall Number: D-0228-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
60 capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 01222015:18@3, Exp 7/21/2015

Recall Number: D-0194-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
6 (10mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 02062015:50@2, Exp 8/25/2015

Recall Number: D-0186-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
180 capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 01162015:59@13, Exp 1/16/2016

Recall Number: D-0202-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
66 (10mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Batch or Lot Expiration Information

Lot# 02022015:66@40, Exp 8/1/2015
Lot# 03022015:62@26, Exp 8/29/2015
Lot# 03062015:66@10, Exp by 9/2/2015

Recall Number: D-0218-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
5 (10mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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, Aurora, IL 60506.

Batch or Lot Expiration Information

Lot# 01162015:90@26, Exp 7/15/2015

Recall Number: D-0182-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
3 (15mL) bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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 Unit 100, Aurora, IL 60506.

Batch or Lot Expiration Information

Lot# 12192014:35@1, Exp 6/17/2015
Lot# 02202015:68@46, Exp 8/19/15

Recall Number: D-0184-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
90 capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 12312014:44@4, Exp 12/31/2015

Recall Number: D-0204-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
12 (10mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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 prefilled, amber syringes, Rx only,The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Batch or Lot Expiration Information

Lot# 01152015:68@24, Exp 7/14/2015; and
Lot# 02192015:15@12, Exp 8/18/2015

Recall Number: D-0227-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
120 capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 12302014:78@17, Exp 12/30/2015
Lot# 03032015:04@4, Exp 3/2/2016

Recall Number: D-0206-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
12 (10mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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 Avenue Unit 100, Aurora, IL 60506.

Batch or Lot Expiration Information

Lot# 01122015:25@6, Exp 7/11/2015
Lot# 03042015:64@14, Exp 8/31/2015

Recall Number: D-0183-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
60 troches

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 12312014:91@6, Exp 3/31/2015

Recall Number: D-0189-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
10 (3mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 03022015:71@18, Exp 8/29/2015

Recall Number: D-0220-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
30 (3mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 12292014:45@12, Exp 6/27/2015
Lot# 01282015:06@16, Exp 7/27/2015
Lot# 03022015:06@38, Exp 8/29/2015

Recall Number: D-0187-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
3 (10mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 01232015:03@14, Exp 4/23/2015

Recall Number: D-0191-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
6 (10mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 01262015:27@46, Exp 8/14/2015

Recall Number: D-0198-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
26 (10mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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 prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Batch or Lot Expiration Information

Lot# 12172014:08@24, Exp 6/15/2015

Recall Number: D-0210-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
20 (3mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 12102014:93@49, Exp 6/8/2015

Recall Number: D-0215-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
3 (10mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 01282015:71@21, Exp 7/27/2015

Recall Number: D-0217-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
6 (10mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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 100, Aurora, IL 60506.

Batch or Lot Expiration Information

Lot# 01132015:27@20, Exp 7/12/2015

Recall Number: D-0216-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
40 (3mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 12172014:36@7, Exp 6/15/2015
Lot# 02202015:63@45, Exp 8/19/2015

Recall Number: D-0219-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
9 (5mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 12102014:82@10, Exp 6/8/2015

Recall Number: D-0223-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
6 (5mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 01232015:87@5, Exp 7/22/2015

Recall Number: D-0201-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
12 (10mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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 prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Batch or Lot Expiration Information

Lot# 01232015:52@49, Exp 7/22/2015

Recall Number: D-0193-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
30 (3mL) syringes, 9 (10mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# a)
Lot# 12162014:22@32, Exp 6/14/2015
Lot# 01122015:42@45, Exp 7/11/2015; b)
Lot# 01212015:65@5, Exp 7/20/2015

Recall Number: D-0224-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
10 (3mL) syringes, 20 (1mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# a)
Lot# 12292014:32@20, Exp 6/27/2015; b)
Lot# 01082015:73@21, Exp 7/7/2015

Recall Number: D-0221-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
20 suppositories

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the product.
ESTRIOL (E3) 2.5MG suppositories, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Batch or Lot Expiration Information

Lot# 01132015:97@2, Exp 4/13/2015

Recall Number: D-0200-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
12 (10mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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 prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Batch or Lot Expiration Information

Lot# 01232015:29@51, Exp 7/22/2015

Recall Number: D-0190-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
5 (3mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 01232015:75@4, Exp 7/22/2015

Recall Number: D-0208-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
1(1mL) syringe, 56 (3mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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 60506.

Batch or Lot Expiration Information

Lot# a)
Lot# 12292014:90@21, Exp 6/27/2015; b)
Lot# 02032015:55@13, Exp 8/2/2015

Recall Number: D-0197-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
18 (10mL) syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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 prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Batch or Lot Expiration Information

Lot# 12112014:43@19, Exp 6/9/2015

Recall Number: D-0213-2016

Reason for Recall
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Initiated
03-10-2015
Reported
11-18-2015
Quantity
120 capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71535
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
the Compounder
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-19-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 02172015:64@24, Exp 5/18/2015