All sterile products within expiry — Class II drug recall D-0012-2015
Terminated recall by Unique Pharmaceutical, Ltd, reported 2014-10-15, distributed nationwide. Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in
| Recall number | D-0012-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Unique Pharmaceutical, Ltd, Temple, TX, United States |
| Recall initiated | 2014-07-18 |
| Classified | 2014-10-09 |
| Reported by FDA | 2014-10-15 |
| Terminated | 2016-02-24 |
| Distributed | Nationwide (US) |
| Quantity | 325,225 units |
| Reason classes | sterility |
Product
All sterile products within expiry
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0012-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.