Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Tri-mix ST9-B, 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 involves a risk-of-harm product (sterile injectable) where injury has not yet been reported, and the agency classification is Class II, which aligns with the 'High' severity criteria for theoretical risks without confirmed illness.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry dates. This recall includes Tri-mix ST9-B, 30 mg/2 mg/100 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable, packaged in clear glass vials. The affected lot is identified as 07202014@8 with an expiration date of 10/18/2014.
The recall was initiated following a recent FDA inspection that identified observations associated with certain quality control procedures. These issues present a risk to the assurance of sterility for the compounded preparations. The distribution pattern for the affected products is nationwide.
Consumers and healthcare providers should stop using the recalled products and contact Martin Avenue Pharmacy, Inc. for further instructions or a replacement. The recall is voluntary and addresses potential sterility risks rather than confirmed contamination or reported illnesses.
The recalled product
- Product
- Tri-mix ST9-B, 30 mg/2 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.
- 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: 07202014@8
- Exp 10/18/2014
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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