Martin Avenue Pharmacy Recalls Tri-mix SEST 4 Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Tri-mix SEST 4 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 states the agency classification is Class II. According to the severity rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when associated with significant risks such as sterility assurance failures in injectable products.
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 SEST 4, 30 mg/1.5 mg/400 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable, packaged in clear glass vials. The recall is initiated in connection with a recent FDA inspection that identified observations associated with certain quality control procedures.
These quality control observations present a risk to the assurance of sterility for the affected products. The recall covers lots with the following identifiers: 07202014@5 (Exp 9/15/2014) and 07152014@1 (Exp 9/30/2014). The distribution pattern for these products is nationwide.
Consumers and healthcare providers should stop using the affected Tri-mix SEST 4 vials and contact Martin Avenue Pharmacy or their healthcare provider for further instructions. The FDA 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 recalled product
- Product
- Tri-mix SEST 4, 30 mg/1.5 mg/400 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: 07202014@5
- Exp 9/15/2014
- 07152014@1
- Exp 9/30/2014
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.
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