FDA Drug recall D-0164-2015
Tri-mix T106, 30 mg/1 mg/25 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, M…
- FDA Drug
- Class II
- terminated
- Published 2014-11-05
On 2014-11-05 the FDA classified a Class II recall of Tri-mix T106, 30 mg/1 mg/25 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, M… by Martin Avenue Pharmacy, citing lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated i….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0164-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-27 |
| Published | 2014-11-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Martin Avenue Pharmacy |
| Distribution | US |
Product
Tri-mix T106, 30 mg/1 mg/25 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
Reason
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Identifiers
| code_info | Lot Number: 06232014@48, Exp 9/21/2014; 06262014@9, Exp 9/24/2014; 08192014@29, Exp 11/17/2014 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0164-2015%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.