FDA Drug recall D-0791-2017
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 (ND…
- FDA Drug
- Class II
- terminated
- Published 2017-05-31
On 2017-05-31 the FDA classified a Class II recall of 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 (ND… by Fagron, citing cGMP Deviations: lack of quality assurance at the API manufacturer.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0791-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-06 |
| Published | 2017-05-31 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fagron |
| Distribution | US |
Product
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
Reason
cGMP Deviations: lack of quality assurance at the API manufacturer.
Identifiers
| code_info | Lot #, Expiration Date: a) 1 G bottle: 16D08-U02-030005, Exp. 3/6/2018; 16F23-U05-033657, Exp. 5/26/2018; 17C02-U02-…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0791-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.