Martin Avenue Pharmacy Recalls Tri-mix Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Tri-mix T108 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, which is a high-risk hazard where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within their expiry date. This action includes Tri-mix T108, 30 mg/1.5 mg/25 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial. The specific lot number is 07142014@43, with an expiration date of 9/30/2014. The product quantity is 40 mL, and the distribution pattern is nationwide.
The recall is being initiated in connection with a recent FDA inspection. During this inspection, observations were made regarding certain quality control procedures that present a risk to sterility assurance. The FDA has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected product immediately. Individuals who have used the recalled product should consult their healthcare provider for guidance. The recall is voluntary and initiated by Martin Avenue Pharmacy, Inc.
The recalled product
- Product
- Tri-mix T108, 30 mg/1.5 mg/25 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: 07142014@43
- Exp 9/30/2014
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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