FDA Drug recall D-1191-2016
HYDROXY B12 5MG/ML IN NACL 0.9% (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY
- FDA Drug
- Class II
- terminated
- Published 2016-07-20
On 2016-07-20 the FDA classified a Class II recall of HYDROXY B12 5MG/ML IN NACL 0.9% (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY by Medaus, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1191-2016 |
| 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
HYDROXY B12 5MG/ML IN NACL 0.9% (PF), In a) 1ML Vials and b) 2ML Vials, MEDAUS PHARMACY
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | a) Lot #: 160119-8, BUD: 07/17/16; Lot #: 160204-30, BUD: 08/02/16. b) Lot #: 160119-8, BUD: 07/17/16; Lot #: 160204-30, BUD: 08/02/16. |
|---|
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-1191-2016%22
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