FDA Drug recall D-1245-2016
TESTOSTERONE CYP 50 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML Vials, and e) 5ML Vials, MEDAUS PHAR…
- FDA Drug
- Class II
- terminated
- Published 2016-07-20
On 2016-07-20 the FDA classified a Class II recall of TESTOSTERONE CYP 50 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML Vials, and e) 5ML Vials, MEDAUS PHAR… by Medaus, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1245-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-13 |
| Published | 2016-07-20 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Medaus |
| Distribution | US |
Product
TESTOSTERONE CYP 50 MG/ML W/PRES (BENZYL ETOH 2%), In a) 1ML Vials, b) 2ML Vials, c) 3ML Vials, d) 4ML Vials, and e) 5ML Vials, MEDAUS PHARMACY
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | a) Lot #: 160119-12, BUD: 07/17/16. b) Lot #: 160119-12, BUD: 07/17/16. c) Lot #: 160119-12, BUD: 07/17/16. d) Lot #…a) Lot #: 160119-12, BUD: 07/17/16. b) Lot #: 160119-12, BUD: 07/17/16. c) Lot #: 160119-12, BUD: 07/17/16. d) Lot #: 160119-12, BUD: 07/17/16. e) Lot #: 160119-12, BUD: 07/17/16. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1245-2016%22
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