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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77060

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

Open FDA event record

Event summary

Timeline bucket
April 06, 2017
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Fagron, Inc

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

Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3), d) 100 G bottle (NDC: 51552-1392-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967 Also packaged as: Estriol USP Micronized, For prescription compounding, packaged in a 100 G bottle (NDC 52372-9292-01), Rx only, Distributed by FREEDOM, 801 W. New Orleans St. Broken Arrow, OK 74011

D-0791-2017
Recall number
D-0791-2017
Initiated
April 06, 2017
Classification
Class II
Status
Terminated
Recalling firm
Fagron, Inc
Quantity
15283 grams

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 at the API manufacturer.

Code information

Lot #, Expiration Date: a) 1 G bottle: 16D08-U02-030005, Exp. 3/6/2018; 16F23-U05-033657, Exp. 5/26/2018; 17C02-U02-035889, Exp. 1/19/2019. b) 5 G bottle: 16D08-U02-030004, 16D08-U02-032486, Exp. 3/6/2018; 16F23-U05-033656, 16F23-U05-035093, Exp. 5/26/2018; 17C02-U02-035890, Exp. 1/19/2019. c) 25 G bottle: 16D08-U02-030003, 16D08-U02-032475, Exp. 3/6/2018; 16F23-U05-033655, 16F23-U05-035092, Exp. 5/26/2018; 17C02-U02-035887, Exp. 1/19/2019. d) 100 G bottle: 16D08-U02-030002, 16D08-U02-032474, Exp. 3/6/2018; 16F23-U05-031158,16F23-U05-033654, 16F23-U05-035091,16G18-F002, Exp. 5/26/2018; 17C02-U02-035888, Exp. 1/19/2019.

Distribution pattern

Nationwide in US and PR and Australia

drug · product 2 of 2

Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b) 5 G bottle (NDC 51552-0445-2), c) 25 G bottle (NDC: 51552-0445-4), d) 100 G bottle (NDC: 51552-0445-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967 Also packaged as: Estrone USP, For Prescription Compounding, packaged in a) 1 G bottle (NDC 52372-9494-01), b) 5 G bottle (NDC 52372-9494-05), c) 25 G bottle (NDC 52372-9494-03), d) 100 G bottle ( NDC 52372-9494-02), Rx only, Distributed by FREEDOM 801 W. New Orleans St. Broken Arrow, OK 74011 Tel. (877) 839-8547

D-0792-2017
Recall number
D-0792-2017
Initiated
April 06, 2017
Classification
Class II
Status
Terminated
Recalling firm
Fagron, Inc
Quantity
1313 grams

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 at the API manufacturer.

Code information

Lot #, Expiration Date: a) 16J05-U01-032346, 16G18-F003A, Exp. 5/17/2018; 16J25-U05-033898, Exp. 5/18/2018. b) 16F23-U04-031011, 16J05-U02-032345, 16G18-F003A, Exp. 5/17/2018; 16J25-U05-033897, 16J25-U05-034708, 16J25-U05-035527, Exp. 5/18/2018; c) 16F23-U04-031024, 16K16-U337-033665, 16G18-F003; 16G18-F003A, Exp. 5/17/2018. d) 16K16-U337-033664, 16G18-F003, Exp. 5/17/2018; 16J25-U05-034707, Exp. 5/18/2018.

Distribution pattern

Nationwide in US and PR and Australia