Estradiol 10 mg pellet 99 — Class II drug recall D-0895-2017
Terminated recall by Qualgen, reported 2017-06-14, distributed nationwide. CGMP deviations- Lack of Quality Assurance
| Recall number | D-0895-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qualgen, Edmond, OK, United States |
| Recall initiated | 2017-04-19 |
| Classified | 2017-06-07 |
| Reported by FDA | 2017-06-14 |
| Terminated | 2021-09-24 |
| Distributed | Nationwide (US) |
| Quantity | 5,260 pellets |
| Reason classes | cgmp |
| NDC | 69761-0010-01 |
| Lot numbers | B046, B079, B107, B140, B160, C021 |
| Expiration dates | 2017-06-01, 2017-08-15, 2017-08-20, 2017-09-29, 2017-11-15, 2017-12-29 |
Product
Estradiol 10 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: 69761-010-01
Reason for recall
CGMP deviations- Lack of Quality Assurance
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0895-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.