Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Tri-mix 8.3 low dose, 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 is classified as FDA Class II and involves a risk to sterility assurance for injectable medications, which poses a significant risk of harm (infection) even though no specific illnesses or injuries are reported in the source text.
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 8.3 low dose (papaverine, phentolamine mesylate, alprostadil) injectable, packaged in clear glass vials. The affected lots are 06252014@32 (Exp 9/23/2014) and 08072014@57 (Exp 11/5/2014).
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 products. The agency has classified this recall as Class II.
The recall is distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If you have these products, you should stop using them and contact Martin Avenue Pharmacy or your healthcare provider for instructions on return or disposal.
The recalled product
- Product
- Tri-mix 8.3 low dose, 22 mg/0.83 mg/8.3 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: 06252014@32
- Exp 9/23/2014
- 08072014@57
- Exp 11/5/2014
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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