Trimix HIGH — Class II drug recall D-1261-2019
Terminated recall by Customceutical Compounding, reported 2019-05-08, distributed nationwide. Lack of assurance of sterility for injectables and solutions intended to be sterile.
| Recall number | D-1261-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Customceutical Compounding, Phoenix, AZ, United States |
| Recall initiated | 2019-04-08 |
| Classified | 2019-04-30 |
| Reported by FDA | 2019-05-08 |
| Terminated | 2023-05-19 |
| Distributed | Nationwide (US) |
| Quantity | 3 vials |
| Reason classes | sterility |
| Expiration dates | 2019-08-02 |
Product
Trimix HIGH (Papaverine HCl 30 mg/mL Phentolamine Mesylate 2 mg/mL Alprostadil 20 mcg/mL), 2 mL multidose vial MDV Inj. Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
Reason for recall
Lack of assurance of sterility for injectables and solutions 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-1261-2019. 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.