D-0225-2019 Class II Terminated
FDA drug recall D-0225-2019 was initiated by Qualgen, LLC on October 17, 2018 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated June 4, 2020).
Recall Details
- Product Type
- Drugs
- Report Date
- November 14, 2018
- Initiation Date
- October 17, 2018
- Termination Date
- June 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide.
Code Information
Lots; C262 BUD: 12/20/2018; D067 BUD: 03/21/2019; D072 BUD: 03/28/2019