Exact FDA event identifier

Event 77064

8 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: April 19, 2017
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Qualgen

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

8 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 8

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,

D-0889-2017

Recall number: D-0889-2017
Initiated: April 19, 2017
Classification: Class II
Status: Terminated
Recalling firm: Qualgen
Quantity: 1,153 pellets.

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP deviations- Lack of Quality Assurance

Code information

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

Distribution pattern

Nationwide.

drug · product 2 of 8

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

D-0890-2017

Recall number: D-0890-2017
Initiated: April 19, 2017
Classification: Class II
Status: Terminated
Recalling firm: Qualgen
Quantity: 1,666 pellets.

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP deviations- Lack of Quality Assurance

Code information

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

Distribution pattern

Nationwide.

drug · product 3 of 8

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

D-0891-2017

Recall number: D-0891-2017
Initiated: April 19, 2017
Classification: Class II
Status: Terminated
Recalling firm: Qualgen
Quantity: 4,468 pellets.

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP deviations- Lack of Quality Assurance

Code 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

Distribution pattern

Nationwide.

drug · product 4 of 8

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.

D-0892-2017

Recall number: D-0892-2017
Initiated: April 19, 2017
Classification: Class II
Status: Terminated
Recalling firm: Qualgen
Quantity: 6,361 pellets.

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP deviations- Lack of Quality Assurance

Code 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

Distribution pattern

Nationwide.

drug · product 5 of 8

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

D-0893-2017

Recall number: D-0893-2017
Initiated: April 19, 2017
Classification: Class II
Status: Terminated
Recalling firm: Qualgen
Quantity: 6,227 pellets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP deviations- Lack of Quality Assurance

Code 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

Distribution pattern

Nationwide.

drug · product 6 of 8

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

D-0894-2017

Recall number: D-0894-2017
Initiated: April 19, 2017
Classification: Class II
Status: Terminated
Recalling firm: Qualgen
Quantity: 4,883 pellets.

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP deviations- Lack of Quality Assurance

Code 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

Distribution pattern

Nationwide.

drug · product 7 of 8

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

D-0895-2017

Recall number: D-0895-2017
Initiated: April 19, 2017
Classification: Class II
Status: Terminated
Recalling firm: Qualgen
Quantity: 5,260 pellets.

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP deviations- Lack of Quality Assurance

Code 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

Distribution pattern

Nationwide.

drug · product 8 of 8

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.

D-0896-2017

Recall number: D-0896-2017
Initiated: April 19, 2017
Classification: Class II
Status: Terminated
Recalling firm: Qualgen
Quantity: 4,815 pellets.

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP deviations- Lack of Quality Assurance

Code 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

Distribution pattern

Nationwide.