Tri-Mix Papaverine/Phentolamine/Alprostadil 150 mg/5 mg/50 mcg a)… — Class II drug recall D-0191-2019
Terminated recall by Pharm D Solutions, LLC, reported 2018-11-07, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0191-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pharm D Solutions, LLC, Houston, TX, United States |
| Recall initiated | 2018-09-10 |
| Classified | 2018-11-01 |
| Reported by FDA | 2018-11-07 |
| Terminated | 2021-02-05 |
| Distributed | Nationwide (US) |
| Quantity | 609 vials |
| Reason classes | sterility |
| NDC | 69699-1332-05 |
Product
Tri-Mix Papaverine/Phentolamine/Alprostadil 150 mg/5 mg/50 mcg a) Injectable NDC 69699-1332-05 b) (LYO) Powder NDC 69699-1332-05, Pharm D Solutions, Houston, Texas
Reason for recall
Lack of Assurance of Sterility
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-0191-2019. 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.