Martin Avenue Pharmacy Recalls Tri-mix ST2 Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Tri-mix ST2 injectable vials because quality control issues identified during an FDA inspection may compromise sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk to sterility assurance for an injectable drug, which is a high-risk product where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. This action specifically includes Tri-mix ST2, 30 mg/3 mg/100 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in clear glass vials. The recall is being initiated in connection with a recent FDA inspection.
The recall was triggered by observations associated with certain quality control procedures that present a risk to sterility assurance. The source text does not specify the exact nature of the quality control failures or the specific lot numbers affected beyond the general scope of 'all compounded sterile preparations within expiry.'
Consumers and healthcare providers who have purchased or received these products should stop using them and contact Martin Avenue Pharmacy or their healthcare provider for instructions on how to return the product. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Tri-mix ST2, 30 mg/3 mg/100 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
- Manufacturer
- Martin Avenue Pharmacy, Inc.
- Category
- Drug — Compounded Injectable
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number: 06252014@33
- Exp 9/23/2014
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 118 recalled by Martin Avenue Pharmacy, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 118 products in this recall →Related recalls
Same manufacturer · Martin Avenue Pharmacy, Inc.
See all →- SevereMartin Avenue Pharmacy Recalls Atropine Sulfate Eye Drops for Sterility Concerns
FDA (Drugs) · 2014-11-05
- SevereMartin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns
FDA (Drugs) · 2014-11-05
- SevereMartin Avenue Pharmacy Recalls Compounded Hydromorphone and Bupivacaine Injections
FDA (Drugs) · 2014-11-05
- HighMartin Avenue Pharmacy Recalls Tri-mix T50 Injectable Due to Sterility Concerns
FDA (Drugs) · 2014-11-05
- HighMartin Avenue Pharmacy Recalls PGE 4 Injectable Due to Sterility Concerns
FDA (Drugs) · 2014-11-05
Same hazard · sterility risk
See all →- SevereFDA Recalls Rohto Dry-Aid Eye Drops Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighMedline Medical Procedure Kits Recalled for High Endotoxin Levels
FDA (Devices) · 2026-05-06
- HighCook Medical pneumothorax tray labeled with an overstated expiration date
FDA (Devices) · 2026-04-15
- HighCook Medical chest tube tray labeled with an overstated expiration date
FDA (Devices) · 2026-04-15
- HighCook Medical CTO-18 wire guides labeled with overstated expiration dates
FDA (Devices) · 2026-04-15