Martin Avenue Pharmacy Recalls Tri-mix T105 Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Tri-mix T105 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 without reported illnesses or injuries, which aligns with the 'High' severity criteria 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 T105, 30 mg/1 mg/10 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable, packaged in clear glass vials. The recall covers a total quantity of 1,150 mL 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. The agency classification for this recall is Class II.
Consumers and healthcare providers who have purchased or received this product should stop using it and contact Martin Avenue Pharmacy, Inc. or their healthcare provider for instructions on return or replacement. The affected lot numbers and expiration dates are: 06102014@44 (Exp 9/8/2014), 06262014@8 (Exp 9/24/2014), 07182014@30 (Exp 10/16/2014), 07302014@16 (Exp 10/28/2014), 08062014@29 (Exp 11/4/2014), and 08132014@37 (Exp 11/11/2014).
The recalled product
- Product
- Tri-mix T105, 30 mg/1 mg/10 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 (12)
- Lot Number: 06102014@44
- Exp 9/8/2014
- 06262014@8
- Exp 9/24/2014
- 07182014@30
- Exp 10/16/2014
- 07302014@16
- Exp 10/28/2014
- 08062014@29
- Exp 11/4/2014
- 08132014@37
- Exp 11/11/2014
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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