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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80203

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

Open FDA event record

Event summary

Timeline bucket
June 08, 2018
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Qualgen, LLC

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

Complete imported group

Every recalled product in this event

2 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 2

ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-020-01

D-0892-2018
Recall number
D-0892-2018
Initiated
June 08, 2018
Classification
Class III
Status
Terminated
Recalling firm
Qualgen, LLC
Quantity
2,940 pellets

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date.

Code information

lot# C211 Exp. date 10/03/2018; C257 Exp. date 12/14/2018 and lot # D001 exp. date 01/02/19

Distribution pattern

Nationwide in the USA

drug · product 2 of 2

TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-120-01

D-0893-2018
Recall number
D-0893-2018
Initiated
June 08, 2018
Classification
Class III
Status
Terminated
Recalling firm
Qualgen, LLC
Quantity
Unavailable

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Incorrect or Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date.

Code information

lot# D001 EXP: 01/02/2018 CPD: 01/02/2019

Distribution pattern

Nationwide in the USA