Martin Avenue Pharmacy Recalls Tri-mix ST1 Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Tri-mix ST1 injectable vials because FDA inspection findings raised concerns about sterility assurance.
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 category. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. The specific product identified is Tri-mix ST1, 30 mg/1.5 mg/50 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable, packaged in clear glass vials. The recall covers lots 06102014@38, 06122014@9, 07152014@59, and 07302014@23, with expiration dates ranging from September 8, 2014, to October 28, 2014.
The recall was initiated following a recent FDA inspection that identified observations associated with certain quality control procedures. These observations present a risk to the assurance of sterility for the compounded preparations. The source text does not report any specific illnesses or injuries associated with the use of these products.
The distribution pattern for the recalled product is listed as nationwide. Consumers and healthcare providers should stop using the affected Tri-mix ST1 vials and contact Martin Avenue Pharmacy or their healthcare provider for further instructions on disposal or replacement.
The recalled product
- Product
- Tri-mix ST1, 30 mg/1.5 mg/50 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 (8)
- Lot Number 06102014@38
- Exp 9/8/2014
- 06122014@9
- Exp 9/10/2014
- 07152014@59
- Exp 9/30/2014
- 07302014@23
- Exp 10/28/2014
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