Martin Avenue Pharmacy Recalls Tri-mix Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Tri-mix injectable vials because FDA inspection findings raised concerns about sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 dates. The specific product identified is Tri-mix, 30 mg/3 mg/5 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable, packaged in a clear glass injectable vial. The recall is associated with Lot Number 07302014@33, which has an expiration date of 10/28/2014.
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 sterility assurance. The source text does not specify the number of units recalled or the specific geographic distribution beyond the pharmacy's location in Naperville, IL.
Consumers and healthcare providers should stop using the recalled product. The source text does not provide specific instructions for disposal or return, nor does it report any illnesses or injuries associated with the use of these products.
The recalled product
- Product
- Tri-mix, 30 mg/3 mg/5 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: 07302014@33
- Exp 10/28/2014
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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