Martin Avenue Pharmacy Recalls Compounded Sterile Preparations for Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including phentolamine mesylate, due to quality control issues affecting 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 is classified as FDA Class II and involves a risk to sterility assurance, which is a high-risk hazard for sterile preparations, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. This recall includes specific lots of Phentolamine mesylate 5 mg/35 mg/mannitol trituration packaged in white jars. The affected products were distributed nationwide.
The recall was initiated following a recent FDA inspection that identified observations associated with certain quality control procedures. These procedures present a risk to the assurance of sterility for the compounded preparations. The agency classification for this recall is Class II.
Consumers who have these products should stop using them and contact Martin Avenue Pharmacy, Inc. or their healthcare provider for instructions on disposal or replacement. The recall covers all compounded sterile preparations within expiry, not just the specific phentolamine lot listed.
The recalled product
- Product
- Phentolamine mesylate 5 mg/35 mg/mannitol trituration packaged in a white jar, 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 (6)
- Lot Number: 04032014@14
- Exp 9/30/2014
- 07152014@36
- Exp 1/11/2015
- 07242014@21
- Exp 1/20/2015
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