Martin Avenue Pharmacy Recalls Tri-mix Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Tri-mix T106 injectable vials because FDA inspection observations 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 product, which is a high-risk hazard where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of Tri-mix T106, a compounded sterile preparation containing papaverine, phentolamine mesylate, and alprostadil. The product is packaged in clear glass injectable vials. The recall covers 420 mL of product distributed nationwide.
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 affected lots include 06232014@48 (Exp 9/21/2014), 06262014@9 (Exp 9/24/2014), and 08192014@29 (Exp 11/17/2014).
Consumers and healthcare providers should stop using the recalled product and contact Martin Avenue Pharmacy or their healthcare provider for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Tri-mix T106, 30 mg/1 mg/25 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 (6)
- Lot Number: 06232014@48
- Exp 9/21/2014
- 06262014@9
- Exp 9/24/2014
- 08192014@29
- Exp 11/17/2014
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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