Martin Avenue Pharmacy Recalls Tri-mix Injectable Due to Sterility Concerns
Martin Avenue Pharmacy is voluntarily recalling Tri-mix injectable vials because quality control observations during an FDA inspection raised concerns about sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the rubric, an FDA Class II recall involving a risk to sterility assurance (a significant injury risk) corresponds to a severity score of 4 (Severe).
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 ST9-E, 30 mg/4 mg/150 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable, packaged in clear glass vials. The recall covers lots 03142014@14 (expiring 9/10/2014) and 08062014@49 (expiring 1/20/2015). 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 sterility assurance. The agency classification for this recall is Class II.
Consumers and healthcare providers who have this product should stop using it and contact Martin Avenue Pharmacy, Inc. or their healthcare provider for instructions on return or disposal. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Tri-mix ST9-E, 30 mg/4 mg/150 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.
- Category
- Drug — Compounded Injectable
- 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: 03142014@14
- Exp 9/10/2014
- 08062014@49
- Exp 1/20/2015
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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