Drug recall
Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06), 12 count (NDC 69761-010-12)…
FDA recall event 81346 · Class II · Qualgen, LLC
Key facts
| Event ID | 81346 |
|---|---|
| Recall numbers | D-0225-2019, D-0226-2019, D-0227-2019, D-0228-2019, D-0229-2019, D-0230-2019, D-0231-2019, D-0232-2019, D-0233-2019, D-0234-2019, D-0235-2019, D-0236-2019 and 2 more |
| Recalling firm | Qualgen, LLC |
| Product type | Drugs |
| Products | Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06), 12 count (NDC 69761-010-12), and 30 count (NDC 69761-010-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013, 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, Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count (NDC 69761-015-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013, Estradiol 18mg pellet, 1 count (NDC 69761-018-01), 6 count (NDC 69761-018-06), 12 count (NDC 69761-018-12), and 30 count (NDC 69761-018-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013, Estradiol 25mg pellet, 1 count (NDC 69761-025-01), 6 count (NDC 69761-025-06), 12 count (NDC 69761-025-12), and 30 count (NDC 69761-025-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013 and 9 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility |
| Initiation date | Oct 17, 2018 |
| Report date | Nov 14, 2018 |
| Termination date | Jun 4, 2020 |
| City | Edmond |
| State | OK |
| Country | United States |
| FEI number | 3011286349 |
At a glance
- 10–99 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: