Martin Avenue Pharmacy Recalls Tri-mix ST5 Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Tri-mix ST5 injectable vials due to quality control observations that present a risk to sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), particularly given the risk to sterility assurance which implies a potential for significant injury.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. This recall specifically includes Tri-mix ST5, 30 mg/1.5 mg/300 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial. The affected products are identified by Lot Numbers 08122014@40 (Exp 9/30/2014) and 08122014@42 (Exp 11/10/2014).
The recall was initiated in connection with a recent FDA inspection. During the inspection, observations were made regarding certain quality control procedures that present a risk to sterility assurance. The agency has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recall is distributed nationwide. Consumers and healthcare providers should stop using the affected products and contact Martin Avenue Pharmacy, Inc. or their healthcare provider for further instructions on disposal or replacement.
The recalled product
- Product
- Tri-mix ST5, 30 mg/1.5 mg/300 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.
- 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 (4)
- Lot Number: 08122014@40
- Exp 9/30/2014
- 08122014@42
- Exp 11/10/2014
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 Tri-mix ST2 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