FDA Drug recall D-0893-2017
Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles
- FDA Drug
- Class II
- terminated
- Published 2017-06-14
On 2017-06-14 the FDA classified a Class II recall of Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles by Qualgen, citing CGMP deviations- Lack of Quality Assurance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0893-2017 |
| 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 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles. Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-015-01
Reason
CGMP deviations- Lack of Quality Assurance
Identifiers
| code_info | Lot# C028; Exp. 02/28/18 Lot# C005; Exp. 07/11/17 Lot# B142; Exp. 11/21/17 Lot# B114; Exp. 10/10/17 Lot# B099; Exp.…Lot# C028; Exp. 02/28/18 Lot# C005; Exp. 07/11/17 Lot# B142; Exp. 11/21/17 Lot# B114; Exp. 10/10/17 Lot# B099; Exp. 09/16/17 Lot# B069; Exp. 07/12/17 Lot# B048; Exp. 06/6/17 |
|---|
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-0893-2017%22
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