Compounded Plaquex — Class II drug recall D0384-2015
Terminated recall by AnazaoHealth Corporation, reported 2015-02-18, distributed nationwide. Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapprove
| Recall number | D0384-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AnazaoHealth Corporation, Las Vegas, NV, United States |
| Recall initiated | 2015-01-26 |
| Classified | 2015-02-09 |
| Reported by FDA | 2015-02-18 |
| Terminated | 2015-02-09 |
| Distributed | Nationwide (US) |
| Quantity | 51 vials |
| Reason classes | cgmp, unapproved product |
| Lot numbers | 05/26/205, 112614-1MC-82186, 112614-1MC-82187, 112614-1MC-82188, 112614-1MC-82189 |
| Expiration dates | 2015-05-26 |
Product
Compounded Plaquex, intravenous injection, 50 ML vial. Each ml contains: Phosphatidyl Choline 50 mg, Sodium Deoxycholate 25 mg, Benzyl Alcohol 0.9%, Ethanol (95%) 2.4 mg di Alpha Tocopheryl Acetate 0.2 mg in Sterile Water for injection.
Reason for recall
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
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/D0384-2015. 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.