FDA Drug recall D-0892-2017
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, Subc…
- FDA Drug
- Class II
- terminated
- Published 2017-06-14
On 2017-06-14 the FDA classified a Class II recall of 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, Subc… by Qualgen, citing CGMP deviations- Lack of Quality Assurance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0892-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-19 |
| Published | 2017-06-14 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Qualgen |
| Distribution | US |
Product
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.
Reason
CGMP deviations- Lack of Quality Assurance
Identifiers
| code_info | 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. 0…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 |
|---|
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-0892-2017%22
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