The firm is recalling all lots of sterile products compounded by the… — Class II drug recall D-1066-2014
Terminated recall by Apothecure, Inc, reported 2014-02-12, distributed nationwide. Lack of Assurance of Sterility: The recall is being initiated due to the lack of sterility assurance and conce
| Recall number | D-1066-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apothecure, Inc, Dallas, TX, United States |
| Recall initiated | 2013-04-15 |
| Classified | 2014-02-04 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2016-12-09 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
Product
The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry.
Reason for recall
Lack of Assurance of Sterility: The recall is being initiated due to the lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.
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-1066-2014. 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.