FDA Drug recall D-0012-2015
All sterile products within expiry
- FDA Drug
- Class II
- terminated
- Published 2014-10-15
On 2014-10-15 the FDA classified a Class II recall of All sterile products within expiry by Unique Pharmaceutical, citing lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0012-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-18 |
| Published | 2014-10-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Unique Pharmaceutical |
| Distribution | US |
Product
All sterile products within expiry
Reason
Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.
Identifiers
| code_info | All Lots |
|---|
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-0012-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.