FDA Drug recall D-0312-2017
TriMix, Alprostadil/Phentolamine/Papaverine 20mcg/1mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
- FDA Drug
- Class II
- ongoing
- Published 2017-01-11
On 2017-01-11 the FDA classified a Class II recall of TriMix, Alprostadil/Phentolamine/Papaverine 20mcg/1mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy by Tri Coast Pharmacy, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0312-2017 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2016-11-17 |
| Published | 2017-01-11 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Tri Coast Pharmacy |
| Distribution | US |
Product
TriMix, Alprostadil/Phentolamine/Papaverine 20mcg/1mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06152…Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06152016D (07/17/2016), 07272016D (09/08/2016), 10252016I (12/09/2016), 10172016A (11/24/2016), 10202016A (11/24/2016). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0312-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.