Martin Avenue Pharmacy Recalls Tri-mix Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Tri-mix injectable vials due to quality control observations that present a risk to 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 rubric 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 date. The specific product identified is Tri-mix, 30 mg/2 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable, packaged in a clear glass injectable vial with a silver crimp top. The affected lot number is 08182014@23, with an expiration date of 11/16/2014. The product was distributed nationwide.
The recall was initiated following a recent FDA inspection. During the inspection, observations were made regarding certain quality control procedures that present a risk to the assurance of sterility for the compounded preparations. This lack of assurance of sterility is the primary reason for the recall.
Consumers and healthcare providers who have this specific lot of Tri-mix should stop using it and contact Martin Avenue Pharmacy or their healthcare provider for further instructions. No illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Tri-mix, 30 mg/2 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial with silver crimp top and sold under the Martin Avenue Pharmacy brand.
- 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: 08182014@23
- Exp 11/16/2014
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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