Bimix Inj 30:0 — Class II drug recall D-454-2013
Terminated recall by Nora Apothecary and Alternative Therapies, Inc., reported 2013-06-05, distributed nationwide. Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control process
| Recall number | D-454-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nora Apothecary and Alternative Therapies, Inc., Indianapolis, IN, United States |
| Recall initiated | 2013-04-22 |
| Classified | 2013-05-29 |
| Reported by FDA | 2013-06-05 |
| Terminated | 2014-08-01 |
| Distributed | Nationwide (US) |
| Quantity | 5 |
| Reason classes | sterility |
Product
Bimix Inj 30:0.5 MDV, 5 ml syr Penile Injection, 90 day expiration,
Reason for recall
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
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-454-2013. 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.