FDA Drug recall D-0226-2019
Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 count (NDC 69761-012-3…
- FDA Drug
- Class II
- terminated
- Published 2018-11-14
On 2018-11-14 the FDA classified a Class II recall of Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 count (NDC 69761-012-3… by Qualgen, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0226-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-17 |
| Published | 2018-11-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Qualgen |
| Distribution | US |
Product
Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 count (NDC 69761-012-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lots: C236 BUD: 11/13/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0226-2019%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.