FDA Drug recall D-0153-2015
Tri-mix 8.3 low dose, 22 mg/0.83 mg/8.3 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass inject…
- FDA Drug
- Class II
- terminated
- Published 2014-11-05
On 2014-11-05 the FDA classified a Class II recall of Tri-mix 8.3 low dose, 22 mg/0.83 mg/8.3 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass inject… 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-0153-2015 |
| 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 8.3 low dose, 22 mg/0.83 mg/8.3 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: 06252014@32, Exp 9/23/2014; 08072014@57, Exp 11/5/2014 |
|---|
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-0153-2015%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.