Multi-event April 2017 FDA Recall Drug by Qualgen

This Multi-event Class II drug recall was voluntarily initiated by Qualgen on April 19, 2017 for the product Drug. The FDA reported the reason for recall as cgmp deviations- lack of quality assurance. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0895-2017 TERMINATED D-0894-2017 TERMINATED D-0890-2017 TERMINATED D-0892-2017 TERMINATED D-0893-2017 TERMINATED D-0891-2017 TERMINATED D-0889-2017 TERMINATED D-0896-2017 TERMINATED

Recall Number: D-0895-2017

Reason for Recall
CGMP deviations- Lack of Quality Assurance
Initiated
04-19-2017
Reported
06-14-2017
Quantity
5,260 pellets.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77064
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.
Qualgen
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-24-2021
Product Description About Product Description
Full technical description of the product.
Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only , For Subcutaneous Use Only Rx Only Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-010-01

Batch or Lot Expiration Information

Lot# C021; Exp. 08/20/17
Lot# B160, Exp. 12/29/17
Lot# B140; Exp. 11/15/17
Lot# B107; Exp. 09/29/17
Lot# B079; Exp. 08/15/17
Lot# B046; Exp. 06/01/17

Recall Number: D-0894-2017

Reason for Recall
CGMP deviations- Lack of Quality Assurance
Initiated
04-19-2017
Reported
06-14-2017
Quantity
4,883 pellets.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77064
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.
Qualgen
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-24-2021
Product Description About Product Description
Full technical description of the product.
Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-012-01

Batch or Lot Expiration Information

Lot# C044; Exp. 03/14/18
Lot# C013; Exp. 07/23/17
Lot# B150; Exp. 12/6/17
Lot# B119; Exp. 10/18/17
Lot# B097; Exp. 09/14/17
Lot# B061; Exp. 07/5/17

Recall Number: D-0890-2017

Reason for Recall
CGMP deviations- Lack of Quality Assurance
Initiated
04-19-2017
Reported
06-14-2017
Quantity
1,666 pellets.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77064
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.
Qualgen
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-24-2021
Product Description About Product Description
Full technical description of the product.
Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-022-01

Batch or Lot Expiration Information

Lot# B128; Exp. 11/1/17
Lot# B075; Exp. 08/3/17

Recall Number: D-0892-2017

Reason for Recall
CGMP deviations- Lack of Quality Assurance
Initiated
04-19-2017
Reported
06-14-2017
Quantity
6,361 pellets.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77064
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.
Qualgen
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-24-2021
Product Description About Product Description
Full technical description of the product.
Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-018-01.

Batch or Lot Expiration Information

Lot# C018; Exp. 08/2/17
Lot# B151; Exp. 12/7/17
Lot# B108; Exp. 10/3/17
Lot# B095; Exp. 09/12/17
Lot# B062; Exp. 07/6/17
Lot# B035; Exp. 05/2/17
Lot# B133; Exp. 11/4/17

Recall Number: D-0893-2017

Reason for Recall
CGMP deviations- Lack of Quality Assurance
Initiated
04-19-2017
Reported
06-14-2017
Quantity
6,227 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77064
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.
Qualgen
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-24-2021
Product Description About Product Description
Full technical description of the product.
Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles. Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-015-01

Batch or Lot Expiration Information

Lot# C028; Exp. 02/28/18
Lot# C005; Exp. 07/11/17
Lot# B142; Exp. 11/21/17
Lot# B114; Exp. 10/10/17
Lot# B099; Exp. 09/16/17
Lot# B069; Exp. 07/12/17
Lot# B048; Exp. 06/6/17

Recall Number: D-0891-2017

Reason for Recall
CGMP deviations- Lack of Quality Assurance
Initiated
04-19-2017
Reported
06-14-2017
Quantity
4,468 pellets.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77064
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.
Qualgen
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-24-2021
Product Description About Product Description
Full technical description of the product.
Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-020-01

Batch or Lot Expiration Information

Lot# C022; Exp. 08/21/17
Lot# B143; Exp. 11/22/17
Lot# B104; Exp. 09/27/17
Lot# B073; Exp. 08/1/17
Lot# B052; Exp. 06/13/17

Recall Number: D-0889-2017

Reason for Recall
CGMP deviations- Lack of Quality Assurance
Initiated
04-19-2017
Reported
06-14-2017
Quantity
1,153 pellets.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77064
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.
Qualgen
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-24-2021
Product Description About Product Description
Full technical description of the product.
Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only. Rx Only ,Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-025-01,

Batch or Lot Expiration Information

Lot# C031; Exp. 03/2/18
Lot# B077; Exp. 08/10/17
Lot# B040; Exp. 05/16/17

Recall Number: D-0896-2017

Reason for Recall
CGMP deviations- Lack of Quality Assurance
Initiated
04-19-2017
Reported
06-14-2017
Quantity
4,815 pellets.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77064
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.
Qualgen
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-24-2021
Product Description About Product Description
Full technical description of the product.
Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by; Qualgen 14844 Bristol Park Blvd. Edmond, OK 73013 NDC: 69761-006-01.

Batch or Lot Expiration Information

Lot# C046; Exp. 03/15/18
Lot# C025; Exp. 08/23/17
Lot# B159; Exp. 12/28/17
Lot# B121; Exp. 10/10/17
Lot# B118; Exp. 10/17/17
Lot# B086; Exp. 08/29/17
Lot# B068; Exp. 07/11/17
Lot# B053; Exp. 06/14/17
Lot# B034; Exp. 04/26/17