CLASS II Drug recall · Reported 31 May 2017 · FDA Enforcement Report
Estrone, For Prescription Compounding recalled by Fagron
Fagron is recalling Estrone, For Prescription Compounding, distributed nationwide in the US. The recall was initiated on 6 Apr 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0792-2017
- FDA event ID
- 77060
- Recalling firm
- Fagron, Saint Paul, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Apr 2017
- FDA classified
- 19 May 2017
- Reported
- 31 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Compounded Drugs
Timeline
| 6 Apr 2017 | Recall initiated by company | |
| 19 May 2017 | Classified by FDA | +43 days |
| 31 May 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviations: lack of quality assurance at the API manufacturer.
Product as listed by the FDA
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
Where it was distributed
Nationwide in US and PR and Australia
Questions about this recall
Why was it recalled?
cGMP Deviations: lack of quality assurance at the API manufacturer.
Which lots are affected?
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.
Where was it sold?
Nationwide in US and PR and Australia
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 77060| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Estriol, For Prescription Compounding recalled by Fagron | Fagron | Manufacturing (CGMP) Deviations | Nationwide |
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|---|---|---|---|---|---|
| Drug | CLASS II | Nystatin 150 MU, Activity (as is):/mg, bulk powder container recalled | Fagron | Potency & Assay | MN |
| Drug | CLASS II | Nystatin 2 BU, Activity (as is):/mg, bulk powder container recalled | Fagron | Potency & Assay | MN |
| Drug | CLASS II | Nystatin 500 MU, Activity (as is):/mg, bulk powder container recalled | Fagron | Potency & Assay | MN |
| Drug | CLASS II | Nystatin 5BU, Activity (as is):/mg, bulk powder container recalled | Fagron | Potency & Assay | MN |
| Drug | CLASS III | Nandrolone Decanoate recalled by Fagron | Fagron | Potency & Assay | Nationwide |