Multi-event September 2016 FDA Recall Drug by Wells Pharmacy Network, Llc

This Multi-event Class III drug recall was voluntarily initiated by Wells Pharmacy Network, Llc on September 19, 2016 for the product Drug. The FDA reported the reason for recall as superpotent and subpotent drugs. The product was distributed in U.S. and the recall is currently terminated.

Reported Recall Events

D-0127-2017 TERMINATED D-0131-2017 TERMINATED D-0129-2017 TERMINATED D-0126-2017 TERMINATED D-0128-2017 TERMINATED D-0130-2017 TERMINATED D-0132-2017 TERMINATED

Recall Number: D-0127-2017

Reason for Recall
Superpotent and Subpotent drugs
Initiated
09-19-2016
Reported
11-16-2016
Quantity
1 pellet

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75247
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Wells Pharmacy Network, LLC
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.
U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-29-2017
Product Description About Product Description
Full technical description of the product.
Testosterone Cholesterol ,100 mg Pellet, Compounded by: Wells Pharmacy Network

Batch or Lot Expiration Information

Lot# Lot Number 06072016@5, BUD 12/04/2016

Recall Number: D-0131-2017

Reason for Recall
Superpotent and Subpotent drugs
Initiated
09-19-2016
Reported
11-16-2016
Quantity
318 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75247
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.
Wells Pharmacy Network, LLC
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.
U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-29-2017
Product Description About Product Description
Full technical description of the product.
Testosterone 200 mg/Anastrazole 20mg Pellet, Compounded by: Wells Pharmacy Network

Batch or Lot Expiration Information

Lot# Lot Number 08162016@5, BUD: 02/12/2017

Recall Number: D-0129-2017

Reason for Recall
Superpotent and Subpotent drugs
Initiated
09-19-2016
Reported
11-16-2016
Quantity
322 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75247
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Wells Pharmacy Network, LLC
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.
U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-29-2017
Product Description About Product Description
Full technical description of the product.
Testosterone 12.5 mg Pellet, Compounded by: Wells Pharmacy Network

Batch or Lot Expiration Information

Lot# Lot Number 08052016@3, BUD 02/01/2017

Recall Number: D-0126-2017

Reason for Recall
Superpotent and Subpotent drugs
Initiated
09-19-2016
Reported
11-16-2016
Quantity
690 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75247
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.
Wells Pharmacy Network, LLC
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.
U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-29-2017
Product Description About Product Description
Full technical description of the product.
Testosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Network

Batch or Lot Expiration Information

Lot# BUD: 10/04/2016, Lot number 04072016@40 BUD: 12/03/2016, Lot number 06162016@2 BUD: 01/07/2017, Lot number CA07112016@4

Recall Number: D-0128-2017

Reason for Recall
Superpotent and Subpotent drugs
Initiated
09-19-2016
Reported
11-16-2016
Quantity
358 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75247
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.
Wells Pharmacy Network, LLC
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.
U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-29-2017
Product Description About Product Description
Full technical description of the product.
Testosterone 60 mg/Anastrazole 4 mg Pellet, Compounded by: Wells Pharmacy Network

Batch or Lot Expiration Information

Lot# Lot Number 08012016@2, BUD 01/28/2017

Recall Number: D-0130-2017

Reason for Recall
Superpotent and Subpotent drugs
Initiated
09-19-2016
Reported
11-16-2016
Quantity
301 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75247
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Wells Pharmacy Network, LLC
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.
U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-29-2017
Product Description About Product Description
Full technical description of the product.
Estradiol 3 mg Pellet, Compounded by: Wells Pharmacy Network

Batch or Lot Expiration Information

Lot# Lot Number 08082016@1, BUD: 02/04/2017

Recall Number: D-0132-2017

Reason for Recall
Superpotent and Subpotent drugs
Initiated
09-19-2016
Reported
11-16-2016
Quantity
353 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75247
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Wells Pharmacy Network, LLC
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.
U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-29-2017
Product Description About Product Description
Full technical description of the product.
Estradiol 12.5 mg Pellet, Compounded by: Wells Pharmacy Network

Batch or Lot Expiration Information

Lot# Lot Number 08172016@9, BUD: 02/13/2017