Martin Avenue Pharmacy Recalls Tri-mix Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Tri-mix injectable vials because quality control issues may compromise 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 for an injectable drug, which fits the criterion for risk-of-harm products where injury has not yet been reported.
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, 30 mg/1 mg/20 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable, packaged in a clear glass injectable vial. The recall covers 75 mL quantities 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 affected lot numbers are 07142014@39 (Exp 9/30/2014) and 07262014@1 (Exp 10/24/2014).
Consumers and healthcare providers should stop using the recalled product and contact Martin Avenue Pharmacy, Inc. for further instructions or a replacement. 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, 30 mg/1 mg/20 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: 07142014@39
- Exp 9/30/2014
- 07262014@1
- Exp 10/24/2014
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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