FDA Drug recall D-0231-2019
Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12 count (NDC 69761-110-12), and 30 count (NDC 69761-110…
- FDA Drug
- Class II
- terminated
- Published 2018-11-14
On 2018-11-14 the FDA classified a Class II recall of Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12 count (NDC 69761-110-12), and 30 count (NDC 69761-110… by Qualgen, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0231-2019 |
| 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
Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12 count (NDC 69761-110-12), and 30 count (NDC 69761-110-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lots: C232 BUD: 11/3/2018; C239 BUD: 11/14/2018; C246 BUD: 11/29/2018; C260 BUD: 12/19/2018; D004 BUD: 1/4/2019; D017 B…Lots: C232 BUD: 11/3/2018; C239 BUD: 11/14/2018; C246 BUD: 11/29/2018; C260 BUD: 12/19/2018; D004 BUD: 1/4/2019; D017 BUD: 1/18/2019; D023 BUD: 1/26/2019; D053 BUD: 3/6/2019 |
|---|
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-0231-2019%22
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